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

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED DAILY FOR 16 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE AND TYPE 2 DIABETES MELLITUS ON METFORMIN

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	PF-06835919	150 mg once daily
DRUG	PF-06835919	300 mg once daily

Timeline

• Start date: 2019-07-18
• Primary completion: 2021-03-02
• Completion: 2021-03-30
• First posted: 2019-05-31
• Last updated: 2022-05-11
• Results posted: 2022-05-11

Locations

106 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study