drugset / Trial / NCT03969719

A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

NCT03969719

Phase 2 Completed 164 enrolled Pfizer
RandomizedParallel-groupDouble-blindBasic science

Summary

This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.

Timeline

Start
2019-07-18
Primary completion
2021-03-02
Completion
2021-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-06835919 Small molecule 150 mg
Subject PF-06835919 Small molecule 300 mg