drugset / Trial / NCT03985293

A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

NCT03985293

Phase 2 Completed 412 enrolled Pfizer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

Timeline

Start
2019-10-15
Primary completion
2021-06-08
Completion
2021-07-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Danuglipron Small molecule 2.5 mg Oral
Subject Danuglipron Small molecule 10 mg Oral
Subject Danuglipron Small molecule 40 mg Oral
Subject Danuglipron Small molecule 80 mg Oral
Subject Danuglipron Small molecule 120 mg Oral