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A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03985293
Recruitment Status : Completed
First Posted : June 13, 2019
Results First Posted : June 30, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Placebo
Drug: PF-06882961
Enrollment 412
Recruitment Details  
Pre-assignment Details A total of 859 participants were screened in the study, among whom, 412 participants were randomized, and 411 participants were treated with PF-06882961 (Danuglipron)/placebo; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.
Arm/Group Title Placebo PF-06882961 2.5mg BID PF-06882961 10mg BID PF-06882961 40mg BID PF-06882961 80mg BID PF-06882961 120mg BID
Hide Arm/Group Description Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Period Title: DOUBLE-BLIND TREATMENT
Started 66 68 68 71 67 71
Completed 57 54 63 57 47 38
Not Completed 9 14 5 14 20 33
Reason Not Completed
Adverse Event             5             2             3             8             15             24
Lost to Follow-up             1             3             0             3             3             1
No Longer Meets Eligibility Criteria             1             1             0             1             0             0
Other             1             2             0             2             1             0
Protocol Violation             1             2             0             0             0             1
Withdrawal by Subject             0             4             2             0             1             7
Period Title: FOLLOW-UP
Started 57 54 63 57 47 38
Completed 57 54 62 57 47 38
Not Completed 0 0 1 0 0 0
Reason Not Completed
Lost to Follow-up             0             0             1             0             0             0
Arm/Group Title Placebo PF-06882961 2.5mg BID PF-06882961 10mg BID PF-06882961 40mg BID PF-06882961 80mg BID PF-06882961 120mg BID Total
Hide Arm/Group Description Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. Total of all reporting groups
Overall Number of Baseline Participants 66 68 68 71 67 71 411
Hide Baseline Analysis Population Description
A total of 412 participants were assigned to treatment, 411 of whom were treated; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean (SD) Number Analyzed 66 participants 68 participants 68 participants 71 participants 67 participants 71 participants 411 participants
57.9  (10.27) 58.9  (9.30) 58.1  (9.43) 59.6  (8.58) 58.4  (9.18) 58.8  (9.43) 58.6  (9.33)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 66 participants 68 participants 68 participants 71 participants 67 participants 71 participants 411 participants
18-44 Years 6 4 7 2 5 8 32
45-64 Years 44 43 41 45 42 44 259
>=65 Years 16 21 20 24 20 19 120
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 68 participants 71 participants 67 participants 71 participants 411 participants
Female
33
  50.0%
30
  44.1%
33
  48.5%
37
  52.1%
32
  47.8%
37
  52.1%
202
  49.1%
Male
33
  50.0%
38
  55.9%
35
  51.5%
34
  47.9%
35
  52.2%
34
  47.9%
209
  50.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 68 participants 71 participants 67 participants 71 participants 411 participants
Hispanic or Latino
24
  36.4%
22
  32.4%
17
  25.0%
24
  33.8%
23
  34.3%
18
  25.4%
128
  31.1%
Not Hispanic or Latino
42
  63.6%
46
  67.6%
50
  73.5%
47
  66.2%
44
  65.7%
52
  73.2%
281
  68.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.5%
0
   0.0%
0
   0.0%
1
   1.4%
2
   0.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 68 participants 71 participants 67 participants 71 participants 411 participants
White
57
  86.4%
57
  83.8%
53
  77.9%
58
  81.7%
59
  88.1%
59
  83.1%
343
  83.5%
Black or African American
2
   3.0%
4
   5.9%
10
  14.7%
6
   8.5%
1
   1.5%
4
   5.6%
27
   6.6%
Asian
5
   7.6%
7
  10.3%
4
   5.9%
6
   8.5%
6
   9.0%
7
   9.9%
35
   8.5%
Native Hawaiian or Other Pacific Islander
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.4%
2
   0.5%
Not reported
1
   1.5%
0
   0.0%
1
   1.5%
1
   1.4%
1
   1.5%
0
   0.0%
4
   1.0%
Age Range  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 66 participants 68 participants 68 participants 71 participants 67 participants 71 participants 411 participants
59.0
(28 to 76)
59.0
(38 to 74)
60.0
(38 to 75)
61.0
(31 to 75)
58.0
(35 to 75)
60.0
(40 to 74)
59.0
(28 to 76)
1.Primary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
Hide Description HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 52 52 61 55 46 38
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent
-0.02
(-0.22 to 0.19)
-0.49
(-0.70 to -0.28)
-0.91
(-1.11 to -0.72)
-1.03
(-1.23 to -0.83)
-0.96
(-1.18 to -0.74)
-1.18
(-1.41 to -0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.47
Confidence Interval (2-Sided) 90%
-0.76 to -0.18
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.90
Confidence Interval (2-Sided) 90%
-1.18 to -0.62
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.01
Confidence Interval (2-Sided) 90%
-1.30 to -0.73
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.94
Confidence Interval (2-Sided) 90%
-1.24 to -0.65
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.16
Confidence Interval (2-Sided) 90%
-1.47 to -0.86
Estimation Comments PF-06882961 = Test Placebo = Reference
2.Secondary Outcome
Title Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels
Hide Description HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 52 52 61 55 46 38
Measure Type: Number
Unit of Measure: Percentage of Participants
7.7 30.8 54.1 58.2 65.2 60.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.11
Confidence Interval (2-Sided) 90%
1.84 to 14.18
Estimation Comments The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 16.85
Confidence Interval (2-Sided) 90%
6.18 to 45.93
Estimation Comments The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 18.79
Confidence Interval (2-Sided) 90%
7.03 to 50.21
Estimation Comments The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 23.97
Confidence Interval (2-Sided) 90%
8.66 to 66.39
Estimation Comments The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 24.46
Confidence Interval (2-Sided) 90%
8.72 to 68.57
Estimation Comments The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference
3.Secondary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2
Hide Description HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 65 64 67 67 63 69
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent
-0.09
(-0.17 to -0.01)
-0.18
(-0.26 to -0.09)
-0.31
(-0.39 to -0.23)
-0.29
(-0.37 to -0.21)
-0.33
(-0.41 to -0.24)
-0.35
(-0.43 to -0.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1578
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.09
Confidence Interval (2-Sided) 90%
-0.19 to 0.01
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.22
Confidence Interval (2-Sided) 90%
-0.32 to -0.12
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.20
Confidence Interval (2-Sided) 90%
-0.30 to -0.10
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.24
Confidence Interval (2-Sided) 90%
-0.34 to -0.14
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.26
Confidence Interval (2-Sided) 90%
-0.36 to -0.16
Estimation Comments PF-06882961 = Test Placebo = Reference
4.Secondary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4
Hide Description HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 60 58 68 63 54 60
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent
-0.08
(-0.19 to 0.04)
-0.38
(-0.50 to -0.26)
-0.51
(-0.62 to -0.39)
-0.63
(-0.74 to -0.52)
-0.58
(-0.70 to -0.46)
-0.64
(-0.75 to -0.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.30
Confidence Interval (2-Sided) 90%
-0.46 to -0.15
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.43
Confidence Interval (2-Sided) 90%
-0.58 to -0.28
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.55
Confidence Interval (2-Sided) 90%
-0.70 to -0.40
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.50
Confidence Interval (2-Sided) 90%
-0.66 to -0.35
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.56
Confidence Interval (2-Sided) 90%
-0.71 to -0.41
Estimation Comments PF-06882961 = Test Placebo = Reference
5.Secondary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6
Hide Description HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 60 55 66 59 51 52
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent
-0.07
(-0.21 to 0.07)
-0.47
(-0.61 to -0.34)
-0.71
(-0.84 to -0.57)
-0.84
(-0.97 to -0.71)
-0.79
(-0.93 to -0.65)
-0.84
(-0.98 to -0.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.40
Confidence Interval (2-Sided) 90%
-0.59 to -0.22
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.64
Confidence Interval (2-Sided) 90%
-0.81 to -0.46
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.77
Confidence Interval (2-Sided) 90%
-0.95 to -0.59
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.72
Confidence Interval (2-Sided) 90%
-0.91 to -0.53
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.77
Confidence Interval (2-Sided) 90%
-0.95 to -0.59
Estimation Comments PF-06882961 = Test Placebo = Reference
6.Secondary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8
Hide Description HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 56 51 66 58 45 42
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent
-0.13
(-0.29 to 0.03)
-0.50
(-0.66 to -0.34)
-0.78
(-0.93 to -0.62)
-0.97
(-1.13 to -0.82)
-0.92
(-1.09 to -0.76)
-1.02
(-1.18 to -0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0054
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.37
Confidence Interval (2-Sided) 90%
-0.59 to -0.15
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.65
Confidence Interval (2-Sided) 90%
-0.86 to -0.44
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.84
Confidence Interval (2-Sided) 90%
-1.06 to -0.63
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.80
Confidence Interval (2-Sided) 90%
-1.02 to -0.57
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.89
Confidence Interval (2-Sided) 90%
-1.11 to -0.67
Estimation Comments PF-06882961 = Test Placebo = Reference
7.Secondary Outcome
Title Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
Hide Description HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 55 53 63 58 46 38
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percent
-0.09
(-0.28 to 0.10)
-0.53
(-0.72 to -0.34)
-0.88
(-1.06 to -0.70)
-1.06
(-1.25 to -0.88)
-0.91
(-1.12 to -0.71)
-1.11
(-1.32 to -0.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.44
Confidence Interval (2-Sided) 90%
-0.71 to -0.18
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.79
Confidence Interval (2-Sided) 90%
-1.05 to -0.54
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.98
Confidence Interval (2-Sided) 90%
-1.24 to -0.72
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.83
Confidence Interval (2-Sided) 90%
-1.10 to -0.56
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.03
Confidence Interval (2-Sided) 90%
-1.30 to -0.75
Estimation Comments PF-06882961 = Test Placebo = Reference
8.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 2
Hide Description The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 65 64 67 68 63 68
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
-5.58
(-12.66 to 1.49)
-22.72
(-29.78 to -15.65)
-21.96
(-28.91 to -15.01)
-27.79
(-34.60 to -20.98)
-24.18
(-31.28 to -17.08)
-30.92
(-37.66 to -24.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -17.13
Confidence Interval (2-Sided) 90%
-25.94 to -8.33
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -16.38
Confidence Interval (2-Sided) 90%
-25.08 to -7.67
Estimation Comments Difference in LS Mean
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -22.20
Confidence Interval (2-Sided) 90%
-30.88 to -13.53
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -18.59
Confidence Interval (2-Sided) 90%
-27.43 to -9.76
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -25.33
Confidence Interval (2-Sided) 90%
-34.00 to -16.67
Estimation Comments PF-06882961 = Test Placebo = Reference
9.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 4
Hide Description The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 60 58 68 62 55 60
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
-5.98
(-13.62 to 1.66)
-17.77
(-25.46 to -10.09)
-24.66
(-31.98 to -17.35)
-33.42
(-40.83 to -26.00)
-33.34
(-41.25 to -25.44)
-34.06
(-41.52 to -26.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0468
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -11.79
Confidence Interval (2-Sided) 90%
-21.55 to -2.04
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -18.68
Confidence Interval (2-Sided) 90%
-28.12 to -9.25
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -27.44
Confidence Interval (2-Sided) 90%
-37.03 to -17.85
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -27.36
Confidence Interval (2-Sided) 90%
-37.22 to -17.51
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -28.09
Confidence Interval (2-Sided) 90%
-37.72 to -18.45
Estimation Comments PF-06882961 = Test Placebo = Reference
10.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 6
Hide Description The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 60 55 66 60 51 53
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
-0.88
(-8.62 to 6.86)
-16.78
(-24.67 to -8.89)
-26.41
(-33.88 to -18.94)
-30.89
(-38.47 to -23.30)
-28.36
(-36.51 to -20.21)
-32.65
(-40.44 to -24.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -15.90
Confidence Interval (2-Sided) 90%
-25.90 to -5.90
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -25.53
Confidence Interval (2-Sided) 90%
-35.18 to -15.89
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -30.01
Confidence Interval (2-Sided) 90%
-39.80 to -20.21
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -27.48
Confidence Interval (2-Sided) 90%
-37.63 to -17.33
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -31.77
Confidence Interval (2-Sided) 90%
-41.77 to -21.78
Estimation Comments PF-06882961 = Test Placebo = Reference
11.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 8
Hide Description The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 57 53 64 58 48 42
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
-9.10
(-16.80 to -1.41)
-12.73
(-20.53 to -4.93)
-26.23
(-33.57 to -18.89)
-29.74
(-37.26 to -22.23)
-33.22
(-41.36 to -25.09)
-34.31
(-42.46 to -26.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5449
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -3.63
Confidence Interval (2-Sided) 90%
-13.51 to 6.25
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -17.12
Confidence Interval (2-Sided) 90%
-26.62 to -7.63
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -20.64
Confidence Interval (2-Sided) 90%
-30.31 to -10.96
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -24.12
Confidence Interval (2-Sided) 90%
-34.20 to -14.04
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -25.21
Confidence Interval (2-Sided) 90%
-35.44 to -14.97
Estimation Comments PF-06882961 = Test Placebo = Reference
12.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 12
Hide Description The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 55 53 63 58 46 37
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
1.21
(-7.93 to 10.35)
-6.49
(-15.70 to 2.73)
-22.56
(-31.17 to -13.95)
-32.01
(-40.89 to -23.14)
-30.45
(-40.26 to -20.64)
-32.38
(-42.83 to -21.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2940
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -7.70
Confidence Interval (2-Sided) 90%
-19.78 to 4.38
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -23.77
Confidence Interval (2-Sided) 90%
-35.37 to -12.17
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -33.23
Confidence Interval (2-Sided) 90%
-45.05 to -21.40
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -31.66
Confidence Interval (2-Sided) 90%
-44.14 to -19.19
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -33.59
Confidence Interval (2-Sided) 90%
-46.67 to -20.51
Estimation Comments PF-06882961 = Test Placebo = Reference
13.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 16
Hide Description The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 52 52 61 56 45 38
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/dL
1.31
(-7.58 to 10.20)
-12.81
(-21.71 to -3.91)
-24.53
(-32.88 to -16.18)
-30.47
(-39.06 to -21.87)
-25.71
(-35.15 to -16.26)
-31.93
(-41.73 to -22.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0464
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -14.12
Confidence Interval (2-Sided) 90%
-25.77 to -2.47
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -25.84
Confidence Interval (2-Sided) 90%
-37.05 to -14.62
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -31.78
Confidence Interval (2-Sided) 90%
-43.20 to -20.35
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -27.02
Confidence Interval (2-Sided) 90%
-39.03 to -15.01
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -33.24
Confidence Interval (2-Sided) 90%
-45.63 to -20.84
Estimation Comments PF-06882961 = Test Placebo = Reference
14.Secondary Outcome
Title Change From Baseline in Body Weight at Week 2
Hide Description Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 65 64 68 68 63 69
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Kilogram
-0.15
(-0.47 to 0.17)
-0.09
(-0.41 to 0.23)
-0.12
(-0.44 to 0.19)
-0.23
(-0.54 to 0.08)
-0.57
(-0.89 to -0.24)
-0.54
(-0.85 to -0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8011
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-0.33 to 0.44
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9149
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.02
Confidence Interval (2-Sided) 90%
-0.35 to 0.40
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7216
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.08
Confidence Interval (2-Sided) 90%
-0.46 to 0.30
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0758
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.42
Confidence Interval (2-Sided) 90%
-0.80 to -0.03
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0860
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.40
Confidence Interval (2-Sided) 90%
-0.77 to -0.02
Estimation Comments PF-06882961 = Test Placebo = Reference
15.Secondary Outcome
Title Change From Baseline in Body Weight at Week 4
Hide Description Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 61 58 68 63 55 61
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Kilogram
-0.25
(-0.64 to 0.15)
-0.33
(-0.72 to 0.07)
-0.08
(-0.46 to 0.30)
-0.77
(-1.15 to -0.39)
-1.05
(-1.45 to -0.64)
-1.33
(-1.71 to -0.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7898
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.08
Confidence Interval (2-Sided) 90%
-0.59 to 0.42
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5829
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.16
Confidence Interval (2-Sided) 90%
-0.33 to 0.66
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0827
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.52
Confidence Interval (2-Sided) 90%
-1.02 to -0.03
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0101
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.80
Confidence Interval (2-Sided) 90%
-1.31 to -0.29
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.09
Confidence Interval (2-Sided) 90%
-1.59 to -0.59
Estimation Comments PF-06882961 = Test Placebo = Reference
16.Secondary Outcome
Title Change From Baseline in Body Weight at Week 6
Hide Description Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 60 55 66 60 51 53
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Kilogram
-0.09
(-0.57 to 0.40)
-0.19
(-0.68 to 0.31)
-0.32
(-0.78 to 0.15)
-0.83
(-1.31 to -0.36)
-1.69
(-2.20 to -1.19)
-2.34
(-2.83 to -1.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7985
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.10
Confidence Interval (2-Sided) 90%
-0.75 to 0.55
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5484
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.23
Confidence Interval (2-Sided) 90%
-0.86 to 0.40
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0541
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.75
Confidence Interval (2-Sided) 90%
-1.38 to -0.11
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.60
Confidence Interval (2-Sided) 90%
-2.26 to -0.95
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -2.25
Confidence Interval (2-Sided) 90%
-2.90 to -1.60
Estimation Comments PF-06882961 = Test Placebo = Reference
17.Secondary Outcome
Title Change From Baseline in Body Weight at Week 8
Hide Description Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 57 54 66 58 48 42
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Kilogram
-0.36
(-0.89 to 0.16)
-0.05
(-0.59 to 0.49)
-0.27
(-0.78 to 0.23)
-1.09
(-1.60 to -0.57)
-1.97
(-2.52 to -1.42)
-3.31
(-3.85 to -2.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4692
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.31
Confidence Interval (2-Sided) 90%
-0.40 to 1.03
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8274
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-0.60 to 0.78
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0887
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.72
Confidence Interval (2-Sided) 90%
-1.42 to -0.02
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -1.61
Confidence Interval (2-Sided) 90%
-2.33 to -0.88
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -2.95
Confidence Interval (2-Sided) 90%
-3.67 to -2.22
Estimation Comments PF-06882961 = Test Placebo = Reference
18.Secondary Outcome
Title Change From Baseline in Body Weight at Week 12
Hide Description Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 55 53 63 58 46 38
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Kilogram
-0.24
(-0.85 to 0.38)
-0.09
(-0.72 to 0.53)
-0.00
(-0.59 to 0.58)
-1.05
(-1.65 to -0.44)
-2.52
(-3.17 to -1.87)
-3.81
(-4.46 to -3.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7758
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.15
Confidence Interval (2-Sided) 90%
-0.70 to 0.99
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6367
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.23
Confidence Interval (2-Sided) 90%
-0.58 to 1.05
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1082
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.81
Confidence Interval (2-Sided) 90%
-1.63 to 0.02
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -2.28
Confidence Interval (2-Sided) 90%
-3.14 to -1.42
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -3.57
Confidence Interval (2-Sided) 90%
-4.44 to -2.70
Estimation Comments PF-06882961 = Test Placebo = Reference
19.Secondary Outcome
Title Change From Baseline in Body Weight at Week 16
Hide Description Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 52 53 62 57 46 38
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Kilogram
-0.43
(-1.12 to 0.25)
0.02
(-0.68 to 0.72)
-0.06
(-0.71 to 0.60)
-1.16
(-1.84 to -0.49)
-2.48
(-3.20 to -1.75)
-4.60
(-5.34 to -3.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 2.5 BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4325
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.45
Confidence Interval (2-Sided) 90%
-0.50 to 1.41
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 10 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4978
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value 0.38
Confidence Interval (2-Sided) 90%
-0.54 to 1.30
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 40 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1970
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -0.73
Confidence Interval (2-Sided) 90%
-1.66 to 0.20
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 80 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -2.04
Confidence Interval (2-Sided) 90%
-3.01 to -1.07
Estimation Comments PF-06882961 = Test Placebo = Reference
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, PF-06882961 120 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed Model Repeated Measures (MMRM)
Method of Estimation Estimation Parameter Difference in LS Mean
Estimated Value -4.17
Confidence Interval (2-Sided) 90%
-5.15 to -3.18
Estimation Comments PF-06882961 = Test Placebo = Reference
20.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])
Hide Description An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Time Frame Baseline up to Week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 66 68 68 71 67 71
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Participants With Treatment Emergent AEs
32
  48.5%
32
  47.1%
31
  45.6%
42
  59.2%
43
  64.2%
44
  62.0%
Number of Participants With Treatment Emergent SAEs
1
   1.5%
1
   1.5%
2
   2.9%
6
   8.5%
2
   3.0%
1
   1.4%
21.Secondary Outcome
Title Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality
Hide Description Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol).
Time Frame Baseline Through Week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 measurement available.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 65 68 68 71 67 71
Measure Type: Count of Participants
Unit of Measure: Participants
60
  92.3%
57
  83.8%
57
  83.8%
57
  80.3%
60
  89.6%
64
  90.1%
22.Secondary Outcome
Title Number of Participants With Treatment Emergent Vital Signs Abnormalities
Hide Description Vital signs abnormality criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP >= 20 mmHg.
Time Frame Baseline through Week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 65 68 68 71 67 71
Measure Type: Count of Participants
Unit of Measure: Participants
Supine SBP <90 mmHg
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Supine SBP increase >=30 mmHg
3
   4.6%
4
   5.9%
3
   4.4%
3
   4.2%
0
   0.0%
5
   7.0%
Supine SBP decrease >=30 mmHg
4
   6.2%
4
   5.9%
3
   4.4%
5
   7.0%
5
   7.5%
0
   0.0%
Supine DBP <50 mmHg
1
   1.5%
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
1
   1.4%
Supine DBP increase >=20 mmHg
1
   1.5%
1
   1.5%
2
   2.9%
3
   4.2%
3
   4.5%
3
   4.2%
Supine DBP decrease >=20 mmHg
3
   4.6%
4
   5.9%
1
   1.5%
3
   4.2%
2
   3.0%
1
   1.4%
Supine pulse rate <40 bpm
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Supine pulse rate >120 bpm
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Participants With Treatment Emergent ECG Abnormalities
Hide Description

ECG categorical abnormality criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (>=) 300 millisecond (msec), b) >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec.

2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) >=140 msec, b) >=50% increase from baseline.

3. QTcF interval (QT corrected using the Fridericia formula): a) >450 msec and <=480 msec, b) >480 msec and <=500 msec, c) >500 msec, d) >30 msec and <=60 msec increase from baseline, e) >60 msec increase from baseline.
Time Frame Baseline Through Week 21
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.
Arm/Group Title Placebo PF-06882961 2.5 BID PF-06882961 10 mg BID PF-06882961 40 mg BID PF-06882961 80 mg BID PF-06882961 120 mg BID
Hide Arm/Group Description:
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
Overall Number of Participants Analyzed 65 68 68 71 67 71
Measure Type: Count of Participants
Unit of Measure: Participants
PR interval ≥300 msec Number Analyzed 65 participants 67 participants 68 participants 71 participants 67 participants 71 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.4%
%Change in PR interval ≥25/50% Number Analyzed 65 participants 67 participants 68 participants 71 participants 67 participants 71 participants
3
   4.6%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.5%
0
   0.0%
QRS interval ≥140 msec Number Analyzed 65 participants 68 participants 68 participants 71 participants 67 participants 71 participants
1
   1.5%
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
%Change in QRS interval ≥50% Number Analyzed 65 participants 68 participants 68 participants 71 participants 67 participants 71 participants
1
   1.5%
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
QTcF interval >450 and ≤480 msec Number Analyzed 65 participants 68 participants 68 participants 71 participants 67 participants 71 participants
2
   3.1%
3
   4.4%
2
   2.9%
1
   1.4%
3
   4.5%
4
   5.6%
QTcF interval >480 and ≤500 msec Number Analyzed 65 participants 68 participants 68 participants 71 participants 67 participants 71 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.4%
QTcF interval >500 msec Number Analyzed 65 participants 68 participants 68 participants 71 participants 67 participants 71 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Change in QTcF interval >30 and ≤60 msec Number Analyzed 65 participants 68 participants 68 participants 71 participants 67 participants 71 participants
2
   3.1%
3
   4.4%
2
   2.9%
6
   8.5%
3
   4.5%
6
   8.5%
Change in QTcF interval >60 msec Number Analyzed 65 participants 68 participants 68 participants 71 participants 67 participants 71 participants
0
   0.0%
0
   0.0%
1
   1.5%
1
   1.4%
0
   0.0%
3
   4.2%
Time Frame Baseline up to Week 21
Adverse Event Reporting Description Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
 
Arm/Group Title Placebo PF-06882961 2.5mg BID PF-06882961 10mg BID PF-06882961 40mg BID PF-06882961 80mg BID PF-06882961 120mg BID
Hide Arm/Group Description Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented. PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
All-Cause Mortality
Placebo PF-06882961 2.5mg BID PF-06882961 10mg BID PF-06882961 40mg BID PF-06882961 80mg BID PF-06882961 120mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/66 (0.00%)   1/68 (1.47%)   0/68 (0.00%)   2/71 (2.82%)   0/67 (0.00%)   0/71 (0.00%) 
Hide Serious Adverse Events
Placebo PF-06882961 2.5mg BID PF-06882961 10mg BID PF-06882961 40mg BID PF-06882961 80mg BID PF-06882961 120mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/66 (1.52%)   1/68 (1.47%)   2/68 (2.94%)   6/71 (8.45%)   2/67 (2.99%)   1/71 (1.41%) 
Blood and lymphatic system disorders             
Anaemia * 1  0/66 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/67 (0.00%)  0/71 (0.00%) 
Cardiac disorders             
Acute myocardial infarction * 1  0/66 (0.00%)  1/68 (1.47%)  0/68 (0.00%)  0/71 (0.00%)  0/67 (0.00%)  0/71 (0.00%) 
Palpitations * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
Hepatobiliary disorders             
Cholecystitis acute * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  1/67 (1.49%)  0/71 (0.00%) 
Drug-induced liver injury * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
Infections and infestations             
COVID-19 pneumonia * 1  0/66 (0.00%)  1/68 (1.47%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
Pneumonia * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
Injury, poisoning and procedural complications             
Ankle fracture * 1  1/66 (1.52%)  0/68 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/67 (0.00%)  0/71 (0.00%) 
Seroma * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
Investigations             
Gamma-glutamyltransferase increased * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
SARS-CoV-2 test positive * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Squamous cell carcinoma * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  0/67 (0.00%)  1/71 (1.41%) 
Nervous system disorders             
Multiple sclerosis * 1  0/66 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  0/71 (0.00%)  0/67 (0.00%)  0/71 (0.00%) 
Paraesthesia * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  1/71 (1.41%)  0/67 (0.00%)  0/71 (0.00%) 
Vascular disorders             
Hypertension * 1  0/66 (0.00%)  0/68 (0.00%)  0/68 (0.00%)  0/71 (0.00%)  1/67 (1.49%)  0/71 (0.00%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo PF-06882961 2.5mg BID PF-06882961 10mg BID PF-06882961 40mg BID PF-06882961 80mg BID PF-06882961 120mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/66 (22.73%)   21/68 (30.88%)   17/68 (25.00%)   33/71 (46.48%)   40/67 (59.70%)   35/71 (49.30%) 
Gastrointestinal disorders             
Abdominal distension * 1  1/66 (1.52%)  0/68 (0.00%)  1/68 (1.47%)  4/71 (5.63%)  3/67 (4.48%)  2/71 (2.82%) 
Diarrhoea * 1  2/66 (3.03%)  3/68 (4.41%)  4/68 (5.88%)  8/71 (11.27%)  12/67 (17.91%)  7/71 (9.86%) 
Dyspepsia * 1  0/66 (0.00%)  4/68 (5.88%)  3/68 (4.41%)  2/71 (2.82%)  9/67 (13.43%)  2/71 (2.82%) 
Gastrooesophageal reflux disease * 1  0/66 (0.00%)  1/68 (1.47%)  2/68 (2.94%)  2/71 (2.82%)  4/67 (5.97%)  5/71 (7.04%) 
Nausea * 1  2/66 (3.03%)  5/68 (7.35%)  5/68 (7.35%)  11/71 (15.49%)  22/67 (32.84%)  23/71 (32.39%) 
Vomiting * 1  0/66 (0.00%)  0/68 (0.00%)  1/68 (1.47%)  5/71 (7.04%)  11/67 (16.42%)  18/71 (25.35%) 
Infections and infestations             
Urinary tract infection * 1  0/66 (0.00%)  1/68 (1.47%)  0/68 (0.00%)  5/71 (7.04%)  3/67 (4.48%)  1/71 (1.41%) 
Investigations             
SARS-CoV-2 test positive * 1  2/66 (3.03%)  4/68 (5.88%)  3/68 (4.41%)  2/71 (2.82%)  1/67 (1.49%)  1/71 (1.41%) 
Metabolism and nutrition disorders             
Decreased appetite * 1  0/66 (0.00%)  2/68 (2.94%)  0/68 (0.00%)  2/71 (2.82%)  1/67 (1.49%)  5/71 (7.04%) 
Hyperglycaemia * 1  6/66 (9.09%)  2/68 (2.94%)  1/68 (1.47%)  0/71 (0.00%)  4/67 (5.97%)  0/71 (0.00%) 
Hypoglycaemia * 1  0/66 (0.00%)  1/68 (1.47%)  1/68 (1.47%)  4/71 (5.63%)  6/67 (8.96%)  3/71 (4.23%) 
Nervous system disorders             
Dizziness * 1  1/66 (1.52%)  1/68 (1.47%)  4/68 (5.88%)  3/71 (4.23%)  1/67 (1.49%)  5/71 (7.04%) 
Headache * 1  4/66 (6.06%)  4/68 (5.88%)  1/68 (1.47%)  5/71 (7.04%)  2/67 (2.99%)  7/71 (9.86%) 
Vascular disorders             
Hypertension * 1  0/66 (0.00%)  1/68 (1.47%)  3/68 (4.41%)  1/71 (1.41%)  4/67 (5.97%)  1/71 (1.41%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03985293    
Other Study ID Numbers: C3421005
2019-000218-12 ( EudraCT Number )
First Submitted: June 11, 2019
First Posted: June 13, 2019
Results First Submitted: June 2, 2022
Results First Posted: June 30, 2022
Last Update Posted: June 30, 2022