Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

• ClinicalTrials.gov Identifier: NCT05158244
• Recruitment Status: Completed
• First Posted: December 15, 2021
• Last Update Posted: June 30, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

This is a Phase 1, randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open study of PF-07081532. Study participants will receive the investigational product or placebo every day for 42 days.

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled type 2 diabetes mellitus, on metformin and optionally in non-diabetic participants with obesity.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: PF-07081532; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official Title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07081532 IN ADULT PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS
• Actual Study Start Date: December 22, 2021
• Actual Primary Completion Date: June 14, 2022
• Actual Study Completion Date: June 14, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: PF-07081532; multiple dosing, once-daily for 42 days	Drug: PF-07081532; Study Drug, once daily for 42 days
Placebo Comparator: Placebo; multiple dosing, once-daily for 42 days	Drug: Placebo; Placebo, once daily for 42 days

Outcome Measures

Primary Outcome Measures :

1. Number of participants with treatment-emergent treatment-related adverse events [ Time Frame: Baseline to minimum 28 days after last administration of investigational product ]
2. Number of participants with clinically significant, abnormal safety laboratory tests [ Time Frame: Baseline to 7-14 days after last administration of investigational product ]
3. Number of participants with clinically significant, abnormal vital sign parameters [ Time Frame: Baseline to 7-14 days after last administration of investigational product ]
4. Number of participants with clinically significant, abnormal 12-lead ECG parameters [ Time Frame: Baseline to 7-14 days after last administration of investigational product ]

Secondary Outcome Measures :

1. Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration [ Time Frame: Day 1 ]
2. Area under the curve from 0 to 24 hours post-dose (AUC24) of PF-07081532 plasma concentration [ Time Frame: Day 42 ]
3. Maximum Observed Plasma Concentration (Cmax) of PF-07081532 [ Time Frame: Day 1 ]
4. Maximum Observed Plasma Concentration (Cmax) of PF-07081532 [ Time Frame: Day 42 ]
5. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532 [ Time Frame: Day 1 ]
6. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07081532 [ Time Frame: Day 42 ]
7. Plasma Decay Half-Life (t1/2) of PF-07081532 [ Time Frame: Day 42 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Females of non childbearing potential;
• Patients with T2DM, inadequately controlled with metformin;
• HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c <6.5% (for non-diabetic obese, if enrolled)
• Total body weight >50 kg (110 lbs)
• BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI >30.5 to ≤45.5 kg/m2 (for non-diabetic obese)

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease;
• Medical history of T2DM (for non-diabetic obese participants, if enrolled);
• Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
• Evidence or history of clinically significant cardiovascular disease;
• Any malignancy not considered cured;
• Acute pancreatitis or history of chronic pancreatitis;
• Acute gallbladder disease;
• Any condition possibly affecting drug absorption;
• Personal or family history of MTC or MEN2;
• Medical or psychiatric condition that may increase the risk of study participation;
• Any vaccination within the 1 week prior to admission to the CRU;
• Previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose;
• Known prior participation in a trial involving PF-07081532;
• A positive urine drug screen at screening or admission;
• Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb;
• Positive COVID-19 test at screening or admission;
• Supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic);
• 12-lead ECG clinically relevant abnormalities that may affect participant safety or interpretation of study results;

• Participants with ANY of the following abnormalities in clinical laboratory tests: *AST or ALT level ≥1.5x ULN;

  • Total bilirubin level ≥1.5x ULN;
  • TSH> ULN;
  • Fasting C-peptide <0.8 ng/mL;
  • Serum calcitonin > ULN;
  • Amylase > ULN;
  • Lipase > ULN;
  • eGFR <60 mL/min/1.73m2 (per MDRD equation);
  • FPG >270 mg/dL
• History of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of Screening;
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing;
• History of sensitivity to heparin or heparin induced thrombocytopenia;
• Known intolerance to any GLP-1R agonist.

Contacts and Locations

Locations

United States, Florida

Qps-Mra, Llc

South Miami, Florida, United States, 33143

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05158244
• Other Study ID Numbers: C3991003
• First Posted: December 15, 2021
• Last Update Posted: June 30, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Type 2 Diabetes Mellitus; Obesity

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases