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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2021-07-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

double-blind (investigator- and participant-blind), sponsor-open

Study Groups

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Active Obesity

Part B

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

Placebo once daily for up to 42 days.

Clopidogrel

Intervention Type DRUG

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.

Placebo Obesity

Part B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo once daily for up to 42 days.

Clopidogrel

Intervention Type DRUG

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.

Active T2DM

Parts A and C

Group Type EXPERIMENTAL

PF-07081532

Intervention Type DRUG

Investigational Drug once daily for up to 42 days; multiple ascending dose design.

Placebo T2DM

Parts A and C

Group Type PLACEBO_COMPARATOR

PF-07081532

Intervention Type DRUG

Investigational Drug once daily for up to 42 days; multiple ascending dose design.

Interventions

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PF-07081532

Investigational Drug once daily for up to 42 days; multiple ascending dose design.

Intervention Type DRUG

Placebo

Placebo once daily for up to 42 days.

Intervention Type OTHER

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.

Intervention Type DRUG

Other Intervention Names

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Plavix

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes