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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Clopidogrel; Other: Placebo; Drug: PF-07081532

Study type: Interventional

Funder types: Industry

Identifiers

NCT04305587

C3991002

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 4 patient groups, including a placebo group

Active Obesity

Experimental group

Description:

Part B

Treatment:

Other: Placebo

Drug: Clopidogrel

Placebo Obesity

Placebo Comparator group

Description:

Part B

Treatment:

Other: Placebo

Drug: Clopidogrel

Active T2DM

Experimental group

Description:

Parts A and C

Treatment:

Drug: PF-07081532

Placebo T2DM

Placebo Comparator group

Description:

Parts A and C

Treatment:

Drug: PF-07081532