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

This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.

Primary Purpose: Basic Science

• Drug: PF-07081532
  
  Investigational Drug once daily for up to 42 days; multiple ascending dose design.
• Other: Placebo
  
  Placebo once daily for up to 42 days.
• Drug: Clopidogrel
  
  Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
  Other Name: Plavix

• Experimental: Active Obesity
  
  Part B
  Interventions:
  

  • Drug: PF-07081532
  • Drug: Clopidogrel
• Placebo Comparator: Placebo Obesity
  
  Part B
  Interventions:
  

  • Other: Placebo
  • Drug: Clopidogrel
• Experimental: Active T2DM
  
  Parts A and C
  Intervention: Drug: PF-07081532
• Placebo Comparator: Placebo T2DM
  
  Parts A and C
  Intervention: Other: Placebo

Key Inclusion Criteria for participants enrolling with T2DM:

• Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
• HbA1c value between 7.0% and 10.5%, inclusive.

Key Exclusion Criterion for participants enrolling with T2DM:

-Type 1 Diabetes or secondary forms of diabetes.

Key Inclusion Criterion for participants enrolling with obesity:

-Obese (as indicated by screening BMI) non-diabetic adults.

Key Exclusion Criterion for participants enrolling with obesity:

--Type 1 or Type 2 Diabetes or secondary forms of diabetes.