NCT05158244

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	PF-07081532	Study Drug, once daily for 42 days
DRUG	Placebo	Placebo, once daily for 42 days

Timeline

• Start date: 2021-12-22
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2021-12-15
• Last updated: 2024-08-12
• Results posted: 2024-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study