A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities

• ClinicalTrials.gov Identifier: NCT05051579
• Recruitment Status: Completed
• First Posted: September 21, 2021
• Results First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Conditions: Obesity; Overweight and Obesity
• Interventions: Drug: LY3502970; Drug: Placebo
• Enrollment: 272

Participant Flow

Recruitment Details
Pre-assignment Details	For maintenance doses of LY3502970: 12, 24, 36, and 45 milligram (mg), the initial dose will be 2 or 3 mg followed by additional escalation steps as appropriate. The dose-escalation varied by dose group where the target maintenance dose was achieved between Weeks 5 and 16.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg -1 LY3502970	36 mg -2 LY3502970	45 mg -1 LY3502970	45 mg -2 LY3502970	Placebo
Arm/Group Description	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg, 6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Period Title: Overall Study
Started	50	53	29	29	31	30	50
Completed	44	46	27	24	23	28	43
Not Completed	6	7	2	5	8	2	7
Reason Not Completed
Withdrawal by Subject	3	5	2	1	4	0	4
Lost to Follow-up	1	0	0	0	1	0	1
Subject Unable to Visit Due to Working Out of Town	0	0	0	0	0	0	1
Adverse Event	2	1	0	4	1	2	0
Inadvertent Enrollment	0	0	0	0	0	0	1
Subject Could not Tolerate Investigational Product (IP) and was Taken Off	0	1	0	0	0	0	0
Sponsor Decision	0	0	0	0	1	0	0
Patient was Initially Long Term Follow-up But Contacted and came to Site After Follow-up	0	0	0	0	1	0	0

Baseline Characteristics

Arm/Group Title		12 mg LY3502970	24 mg LY3502970	36 mg -1 LY3502970	36 mg -2 LY3502970	45 mg -1 LY3502970	45 mg -2 LY3502970	Placebo	Total
Arm/Group Description		Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		50	53	29	29	31	30	50	272
Baseline Analysis Population Description		All randomized participants.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	50 participants	53 participants	29 participants	29 participants	31 participants	30 participants	50 participants	272 participants
		49.80 (10.51)	57.00 (9.09)	56.30 (11.83)	55.40 (10.93)	56.50 (10.74)	50.90 (12.58)	54.00 (8.82)	54.20 (10.67)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants	53 participants	29 participants	29 participants	31 participants	30 participants	50 participants	272 participants
	Female	31	30	18	18	19	16	29	161
	Male	19	23	11	11	12	14	21	111
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants	53 participants	29 participants	29 participants	31 participants	30 participants	50 participants	272 participants
	Hispanic or Latino	11	6	4	2	4	7	5	39
	Not Hispanic or Latino	38	46	23	26	25	22	43	223
	Unknown or Not Reported	1	1	2	1	2	1	2	10
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants	53 participants	29 participants	29 participants	31 participants	30 participants	50 participants	272 participants
	American Indian or Alaska Native	0	1	0	0	0	0	0	1
	Asian	0	0	0	0	0	0	2	2
	Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
	Black or African American	3	6	4	4	1	0	1	19
	White	47	46	25	25	29	30	45	247
	More than one race	0	0	0	0	0	0	2	2
	Unknown or Not Reported	0	0	0	0	1	0	0	1
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	50 participants	53 participants	29 participants	29 participants	31 participants	30 participants	50 participants	272 participants
Canada		9	11	5	3	9	5	6	48
Hungary		6	5	3	6	3	3	5	31
United States		35	37	21	20	19	22	39	193
Baseline Body Weight; Mean (Standard Deviation); Unit of measure: Kilograms (kg)
	Number Analyzed	50 participants	53 participants	29 participants	29 participants	31 participants	30 participants	50 participants	272 participants
		107.49 (25.34)	112.05 (30.18)	107.78 (22.45)	108.84 (28.52)	105.23 (20.40)	110.85 (28.11)	107.57 (25.24)	108.68 (26.03)

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Description	Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Least Squares Mean (Standard Error); Unit of Measure: Percent change
	-8.6 (0.85)	-11.2 (0.82)	-12.3 (0.77)	-12.6 (0.75)	-2.0 (0.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 95%; -8.9 to -4.2
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-9.2
	Confidence Interval	(2-Sided) 95%; -11.5 to -6.9
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-10.2
	Confidence Interval	(2-Sided) 95%; -12.4 to -8.0
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-10.6
	Confidence Interval	(2-Sided) 95%; -12.7 to -8.4
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Percent Change From Baseline in Body Weight in LY3502970 and Placebo
Description	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 36

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Least Squares Mean (Standard Error); Unit of Measure: Percent change
	-9.4 (1.05)	-12.5 (1.01)	-13.5 (0.95)	-14.7 (0.94)	-2.3 (1.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-7.1
	Confidence Interval	(2-Sided) 95%; -9.9 to -4.2
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-10.1
	Confidence Interval	(2-Sided) 95%; -12.9 to -7.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-11.1
	Confidence Interval	(2-Sided) 95%; -13.8 to -8.4
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-12.3
	Confidence Interval	(2-Sided) 95%; -15.0 to -9.6
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Change From Baseline in Body Weight in LY3502970 and Placebo
Description	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Least Squares Mean (Standard Error); Unit of Measure: kg
	-9.0 (0.90)	-12.3 (0.86)	-12.9 (0.82)	-13.3 (0.79)	-2.1 (0.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-6.9
	Confidence Interval	(2-Sided) 95%; -9.3 to -4.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-10.2
	Confidence Interval	(2-Sided) 95%; -12.5 to -7.8
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-10.8
	Confidence Interval	(2-Sided) 95%; -13.1 to -8.5
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-11.2
	Confidence Interval	(2-Sided) 95%; -13.5 to -8.9
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in Body Weight in LY3502970 and Placebo
Description	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 36

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body weight value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Least Squares Mean (Standard Error); Unit of Measure: kg
	-9.8 (1.10)	-13.6 (1.06)	-14.2 (1.00)	-15.4 (0.98)	-2.4 (1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-7.4
	Confidence Interval	(2-Sided) 95%; -10.4 to -4.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-11.2
	Confidence Interval	(2-Sided) 95%; -14.2 to -8.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-11.8
	Confidence Interval	(2-Sided) 95%; -14.7 to -9.0
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-13.0
	Confidence Interval	(2-Sided) 95%; -15.8 to -10.2
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Change From Baseline in Waist Circumference in LY3502970 and Placebo
Description	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	43	49	52	57	48
Least Squares Mean (Standard Error); Unit of Measure: centimeter (cm)
	-8.0 (1.03)	-8.8 (1.00)	-10.1 (0.94)	-12.2 (0.93)	-3.6 (0.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-4.4
	Confidence Interval	(2-Sided) 95%; -7.2 to -1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-5.2
	Confidence Interval	(2-Sided) 95%; -8.0 to -2.4
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 95%; -9.2 to -3.8
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-8.7
	Confidence Interval	(2-Sided) 95%; -11.3 to -6.0
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in Waist Circumference in LY3502970 and Placebo
Description	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 36

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline body waist circumference value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	43	49	52	57	48
Least Squares Mean (Standard Error); Unit of Measure: cm
	-9.6 (1.18)	-11.2 (1.15)	-10.6 (1.06)	-13.6 (1.07)	-4.0 (1.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-5.6
	Confidence Interval	(2-Sided) 95%; -8.8 to -2.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-7.2
	Confidence Interval	(2-Sided) 95%; -10.3 to -4.0
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-6.6
	Confidence Interval	(2-Sided) 95%; -9.7 to -3.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-9.6
	Confidence Interval	(2-Sided) 95%; -12.7 to -6.6
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in BMI in LY3502970 and Placebo
Description	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Least Squares Mean (Standard Error); Unit of Measure: kilograms per meter square (kg/m^2)
	-3.2 (0.31)	-4.2 (0.30)	-4.6 (0.28)	-4.7 (0.27)	-0.8 (0.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-2.4
	Confidence Interval	(2-Sided) 95%; -3.2 to -1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-3.5
	Confidence Interval	(2-Sided) 95%; -4.3 to -2.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95%; -4.6 to 3.0
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-3.9
	Confidence Interval	(2-Sided) 95%; -4.7 to -3.1
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Change From Baseline in BMI in LY3502970 and Placebo
Description	LS mean was determined by MMRM model with Baseline + Baseline BMI Group + Sex + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Time Frame	Baseline, Week 36

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline BMI value.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Least Squares Mean (Standard Error); Unit of Measure: kg/m^2
	-3.4 (0.38)	-4.7 (0.36)	-5.0 (0.34)	-5.5 (0.34)	-0.9 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -3.6 to -1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-3.8
	Confidence Interval	(2-Sided) 95%; -4.8 to -2.8
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-4.2
	Confidence Interval	(2-Sided) 95%; -5.2 to -3.2
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean difference (Final Values)
	Estimated Value	-4.6
	Confidence Interval	(2-Sided) 95%; -5.6 to -3.6
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants With >=5% Body Weight Loss
Description	Percentage of participants with >=5% body weight loss was reported.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Measure Type: Number; Unit of Measure: percentage of participants
	74.39	88.84	89.46	87.26	22.88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9.96
	Confidence Interval	(2-Sided) 95%; 3.61 to 27.44
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	27.97
	Confidence Interval	(2-Sided) 95%; 8.15 to 96.01
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	27.36
	Confidence Interval	(2-Sided) 95%; 8.71 to 85.91
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	23.59
	Confidence Interval	(2-Sided) 95%; 7.65 to 72.77
	Estimation Comments	[Not Specified]

10. Secondary Outcome

Title	Percentage of Participants With >=10% Body Weight Loss
Description	Percentage of participants with >=10% body weight loss was reported.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Measure Type: Number; Unit of Measure: percentage of participants
	39.39	56.61	71.30	69.86	2.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	19.93
	Confidence Interval	(2-Sided) 95%; 3.47 to 114.40
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	39.52
	Confidence Interval	(2-Sided) 95%; 6.95 to 224.83
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	74.97
	Confidence Interval	(2-Sided) 95%; 13.16 to 427.18
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	72.23
	Confidence Interval	(2-Sided) 95%; 12.62 to 413.21
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Percentage of Participants With >=5% Body Weight Loss
Description	Percentage of participants with >=5% body weight loss was reported.
Time Frame	Week 36

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥5% body weight reduction.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Measure Type: Number; Unit of Measure: percentage of participants
	72.00	89.47	92.05	90.44	24.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.79
	Confidence Interval	(2-Sided) 95%; 2.90 to 20.92
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	25.07
	Confidence Interval	(2-Sided) 95%; 7.49 to 83.91
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	34.76
	Confidence Interval	(2-Sided) 95%; 8.17 to 147.86
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	28.01
	Confidence Interval	(2-Sided) 95%; 8.15 to 96.29
	Estimation Comments	[Not Specified]

12. Secondary Outcome

Title	Percentage of Participants With >=10% Body Weight Loss
Description	Percentage of participants with >=10% body weight loss was reported.
Time Frame	Week 36

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline value for ≥10% body weight reduction.

Arm/Group Title	12 mg LY3502970	24 mg LY3502970	36 mg LY3502970	45 mg LY3502970	Placebo
Arm/Group Description:	Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.	Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-1 and dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 in LY 36mg-2 administered orally once daily until 36 weeks.	Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-1 and dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 in LY 45mg-2 administered orally once daily until 36 weeks.	Participants received placebo administered orally once daily until 36 weeks.
Overall Number of Participants Analyzed	44	51	56	57	48
Measure Type: Number; Unit of Measure: percentage of participants
	46.50	61.88	74.75	69.07	8.85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	12 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.27
	Confidence Interval	(2-Sided) 95%; 2.59 to 26.45
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	24 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	15.64
	Confidence Interval	(2-Sided) 95%; 4.83 to 50.68
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	36 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	27.24
	Confidence Interval	(2-Sided) 95%; 8.39 to 88.38
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	45 mg LY3502970, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	20.88
	Confidence Interval	(2-Sided) 95%; 6.59 to 66.17
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame

Baseline through Week 38 (36 weeks with 2 weeks safety follow up)

Adverse Event Reporting Description

All randomized participants who received at least one dose of study drug regardless of adherence to study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.

Arm/Group Title

12 mg LY3502970

24 mg LY3502970

36 Mg-1 LY3502970

36 Mg-2 LY3502970

45 Mg-1 LY3502970

45 Mg-2 LY3502970

Placebo

Arm/Group Description

Participants received maintenance dose 12 mg with dose escalation starting from 3 mg,6 mg and then 12 mg LY3502970 administered orally once daily until 36 weeks.

Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally once daily until 36 weeks.

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.

Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally once daily until 36 weeks.

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.

Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally once daily until 36 weeks.

Participants received placebo administered orally once daily until 36 weeks.

All-Cause Mortality

12 mg LY3502970

24 mg LY3502970

36 Mg-1 LY3502970

36 Mg-2 LY3502970

45 Mg-1 LY3502970

45 Mg-2 LY3502970

Placebo

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/50 (0.00%)

0/53 (0.00%)

0/29 (0.00%)

0/29 (0.00%)

0/31 (0.00%)

0/30 (0.00%)

0/50 (0.00%)

Serious Adverse Events

12 mg LY3502970

24 mg LY3502970

36 Mg-1 LY3502970

36 Mg-2 LY3502970

45 Mg-1 LY3502970

45 Mg-2 LY3502970

Placebo

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

0/50 (0.00%)

2/53 (3.77%)

0/29 (0.00%)

3/29 (10.34%)

2/31 (6.45%)

0/30 (0.00%)

0/50 (0.00%)

Cardiac disorders

Coronary artery disease † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

0/29 (0.00%)

0

1/31 (3.23%)

1

0/30 (0.00%)

0

0/50 (0.00%)

0

Eye disorders

Retinal vein thrombosis † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

1/29 (3.45%)

1

0/31 (0.00%)

0

0/30 (0.00%)

0

0/50 (0.00%)

0

Vitreoretinal traction syndrome † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

0/29 (0.00%)

0

1/31 (3.23%)

1

0/30 (0.00%)

0

0/50 (0.00%)

0

Gastrointestinal disorders

Diverticulum intestinal † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

1/29 (3.45%)

1

0/31 (0.00%)

0

0/30 (0.00%)

0

0/50 (0.00%)

0

Gastrointestinal polyp haemorrhage † 1

0/50 (0.00%)

0

1/53 (1.89%)

1

0/29 (0.00%)

0

0/29 (0.00%)

0

0/31 (0.00%)

0

0/30 (0.00%)

0

0/50 (0.00%)

0

Hepatobiliary disorders

Cholecystitis acute † 1

0/50 (0.00%)

0

1/53 (1.89%)

1

0/29 (0.00%)

0

0/29 (0.00%)

0

0/31 (0.00%)

0

0/30 (0.00%)

0

0/50 (0.00%)

0

Metabolism and nutrition disorders

Hypercalcaemia † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

1/29 (3.45%)

1

0/31 (0.00%)

0

0/30 (0.00%)

0

0/50 (0.00%)

0

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer metastatic † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

1/29 (3.45%)

1

0/31 (0.00%)

0

0/30 (0.00%)

0

0/50 (0.00%)

0

1 Term from vocabulary, MedDRA 25.1; † Indicates events were collected by systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

5%

12 mg LY3502970

24 mg LY3502970

36 Mg-1 LY3502970

36 Mg-2 LY3502970

45 Mg-1 LY3502970

45 Mg-2 LY3502970

Placebo

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

35/50 (70.00%)

46/53 (86.79%)

23/29 (79.31%)

25/29 (86.21%)

26/31 (83.87%)

24/30 (80.00%)

27/50 (54.00%)

Cardiac disorders

Atrioventricular block first degree † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

0/29 (0.00%)

0

0/31 (0.00%)

0

3/30 (10.00%)

3

0/50 (0.00%)

0

Gastrointestinal disorders

Abdominal discomfort † 1

0/50 (0.00%)

0

4/53 (7.55%)

4

1/29 (3.45%)

1

1/29 (3.45%)

1

4/31 (12.90%)

4

0/30 (0.00%)

0

1/50 (2.00%)

1

Abdominal distension † 1

1/50 (2.00%)

1

4/53 (7.55%)

5

0/29 (0.00%)

0

1/29 (3.45%)

1

1/31 (3.23%)

1

2/30 (6.67%)

2

1/50 (2.00%)

1

Abdominal pain † 1

4/50 (8.00%)

4

4/53 (7.55%)

5

0/29 (0.00%)

0

2/29 (6.90%)

2

2/31 (6.45%)

2

1/30 (3.33%)

3

2/50 (4.00%)

2

Abdominal pain upper † 1

1/50 (2.00%)

1

3/53 (5.66%)

3

0/29 (0.00%)

0

2/29 (6.90%)

2

0/31 (0.00%)

0

3/30 (10.00%)

3

1/50 (2.00%)

1

Constipation † 1

12/50 (24.00%)

16

17/53 (32.08%)

21

8/29 (27.59%)

8

7/29 (24.14%)

10

6/31 (19.35%)

8

4/30 (13.33%)

5

3/50 (6.00%)

3

Diarrhoea † 1

12/50 (24.00%)

23

19/53 (35.85%)

29

1/29 (3.45%)

1

4/29 (13.79%)

5

5/31 (16.13%)

5

10/30 (33.33%)

16

5/50 (10.00%)

6

Dyspepsia † 1

8/50 (16.00%)

11

4/53 (7.55%)

4

1/29 (3.45%)

1

1/29 (3.45%)

1

3/31 (9.68%)

3

2/30 (6.67%)

2

3/50 (6.00%)

4

Eructation † 1

9/50 (18.00%)

15

11/53 (20.75%)

14

5/29 (17.24%)

5

2/29 (6.90%)

2

2/31 (6.45%)

2

6/30 (20.00%)

9

0/50 (0.00%)

0

Flatulence † 1

0/50 (0.00%)

0

3/53 (5.66%)

3

0/29 (0.00%)

0

1/29 (3.45%)

1

1/31 (3.23%)

1

0/30 (0.00%)

0

2/50 (4.00%)

2

Gastrooesophageal reflux disease † 1

4/50 (8.00%)

4

5/53 (9.43%)

6

3/29 (10.34%)

3

4/29 (13.79%)

5

4/31 (12.90%)

6

2/30 (6.67%)

2

1/50 (2.00%)

1

Nausea † 1

25/50 (50.00%)

39

31/53 (58.49%)

50

12/29 (41.38%)

18

14/29 (48.28%)

18

13/31 (41.94%)

28

11/30 (36.67%)

23

5/50 (10.00%)

6

Vomiting † 1

13/50 (26.00%)

23

17/53 (32.08%)

33

8/29 (27.59%)

11

4/29 (13.79%)

9

9/31 (29.03%)

14

8/30 (26.67%)

15

3/50 (6.00%)

3

General disorders

Chills † 1

1/50 (2.00%)

1

1/53 (1.89%)

1

1/29 (3.45%)

1

0/29 (0.00%)

0

2/31 (6.45%)

2

0/30 (0.00%)

0

0/50 (0.00%)

0

Fatigue † 1

2/50 (4.00%)

2

7/53 (13.21%)

8

4/29 (13.79%)

4

2/29 (6.90%)

2

4/31 (12.90%)

5

4/30 (13.33%)

6

1/50 (2.00%)

1

Infections and infestations

Covid-19 † 1

9/50 (18.00%)

11

9/53 (16.98%)

9

4/29 (13.79%)

4

7/29 (24.14%)

7

5/31 (16.13%)

5

5/30 (16.67%)

5

9/50 (18.00%)

9

Nasopharyngitis † 1

1/50 (2.00%)

2

2/53 (3.77%)

2

0/29 (0.00%)

0

0/29 (0.00%)

0

1/31 (3.23%)

1

2/30 (6.67%)

2

0/50 (0.00%)

0

Sinusitis † 1

1/50 (2.00%)

1

3/53 (5.66%)

3

1/29 (3.45%)

2

0/29 (0.00%)

0

0/31 (0.00%)

0

2/30 (6.67%)

2

1/50 (2.00%)

1

Upper respiratory tract infection † 1

3/50 (6.00%)

3

0/53 (0.00%)

0

2/29 (6.90%)

3

1/29 (3.45%)

1

1/31 (3.23%)

1

2/30 (6.67%)

2

1/50 (2.00%)

1

Urinary tract infection † 1

2/50 (4.00%)

2

3/53 (5.66%)

4

0/29 (0.00%)

0

3/29 (10.34%)

3

1/31 (3.23%)

1

2/30 (6.67%)

2

3/50 (6.00%)

3

Metabolism and nutrition disorders

Decreased appetite † 1

4/50 (8.00%)

4

4/53 (7.55%)

5

0/29 (0.00%)

0

1/29 (3.45%)

1

3/31 (9.68%)

3

2/30 (6.67%)

2

1/50 (2.00%)

1

Musculoskeletal and connective tissue disorders

Arthralgia † 1

1/50 (2.00%)

1

5/53 (9.43%)

5

1/29 (3.45%)

1

1/29 (3.45%)

1

1/31 (3.23%)

2

1/30 (3.33%)

1

1/50 (2.00%)

1

Back pain † 1

1/50 (2.00%)

1

2/53 (3.77%)

2

1/29 (3.45%)

1

1/29 (3.45%)

1

1/31 (3.23%)

1

1/30 (3.33%)

1

4/50 (8.00%)

4

Muscle spasms † 1

0/50 (0.00%)

0

1/53 (1.89%)

1

1/29 (3.45%)

1

0/29 (0.00%)

0

1/31 (3.23%)

1

2/30 (6.67%)

2

0/50 (0.00%)

0

Myalgia † 1

0/50 (0.00%)

0

1/53 (1.89%)

1

3/29 (10.34%)

3

0/29 (0.00%)

0

0/31 (0.00%)

0

0/30 (0.00%)

0

1/50 (2.00%)

1

Pain in extremity † 1

1/50 (2.00%)

1

1/53 (1.89%)

1

1/29 (3.45%)

1

2/29 (6.90%)

2

0/31 (0.00%)

0

0/30 (0.00%)

0

1/50 (2.00%)

1

Nervous system disorders

Dizziness † 1

5/50 (10.00%)

5

2/53 (3.77%)

3

1/29 (3.45%)

1

1/29 (3.45%)

1

2/31 (6.45%)

2

4/30 (13.33%)

4

1/50 (2.00%)

1

Headache † 1

4/50 (8.00%)

4

8/53 (15.09%)

11

3/29 (10.34%)

3

2/29 (6.90%)

2

4/31 (12.90%)

6

2/30 (6.67%)

3

5/50 (10.00%)

7

Renal and urinary disorders

Dysuria † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

2/29 (6.90%)

3

1/29 (3.45%)

1

1/31 (3.23%)

1

0/30 (0.00%)

0

0/50 (0.00%)

0

Reproductive system and breast disorders

Balanoposthitis † 1

0/19 (0.00%)

0

0/23 (0.00%)

0

1/11 (9.09%)

1

0/11 (0.00%)

0

0/12 (0.00%)

0

0/14 (0.00%)

0

0/21 (0.00%)

0

Erectile dysfunction † 1

1/19 (5.26%)

1

0/23 (0.00%)

0

0/11 (0.00%)

0

0/11 (0.00%)

0

0/12 (0.00%)

0

0/14 (0.00%)

0

0/21 (0.00%)

0

Postmenopausal haemorrhage † 1

0/31 (0.00%)

0

0/30 (0.00%)

0

0/18 (0.00%)

0

1/18 (5.56%)

1

1/19 (5.26%)

1

0/16 (0.00%)

0

0/29 (0.00%)

0

Vulvovaginal pruritus † 1

0/31 (0.00%)

0

0/30 (0.00%)

0

1/18 (5.56%)

1

0/18 (0.00%)

0

0/19 (0.00%)

0

0/16 (0.00%)

0

0/29 (0.00%)

0

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

0/29 (0.00%)

0

2/29 (6.90%)

2

0/31 (0.00%)

0

1/30 (3.33%)

1

1/50 (2.00%)

2

Skin and subcutaneous tissue disorders

Alopecia † 1

1/50 (2.00%)

1

1/53 (1.89%)

1

0/29 (0.00%)

0

0/29 (0.00%)

0

3/31 (9.68%)

3

0/30 (0.00%)

0

1/50 (2.00%)

1

Vascular disorders

Hypotension † 1

0/50 (0.00%)

0

0/53 (0.00%)

0

2/29 (6.90%)

2

0/29 (0.00%)

0

1/31 (3.23%)

1

3/30 (10.00%)

3

0/50 (0.00%)

0

1 Term from vocabulary, MedDRA 25.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

• Name/Title: Chief Medical Officer
• Organization: Eli Lilly and Company
• Phone: 800-545-5979
• EMail: ClinicalTrials.gov@lilly.com

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT05051579
• Other Study ID Numbers: 18210; J2A-MC-GZGI ( Other Identifier: Eli Lilly and Company ); 2021-002805-88 ( EudraCT Number )
• First Submitted: September 17, 2021
• First Posted: September 21, 2021
• Results First Submitted: August 23, 2023
• Results First Posted: September 13, 2023
• Last Update Posted: September 13, 2023