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

• Status: Completed
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Males, or females of nonchildbearing potential

• 18 to 70 years of age

• Type 2 Diabetes Mellitus

• Liver fat >/=8% by MRI-PDFF

• On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Exclusion Criteria:

• History of other liver disease

• Unable to have an MRI performed

• Significant weight loss in the previous month and/or participant in current weight loss program

• History of diabetic complications with end-organ damage