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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT03969719

Run by

Pfizer

People needed

164

Starts

2019-07-18

Expected to finish

2021-03-30

Last updated by the study team

2022-05-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Clinical Research Consortium an AMR company — Tempe, Arizona, United States
• Anaheim Clinical Trials LLC-Clinical Research — Anaheim, California, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Hope Clinical Research — Canoga Park, California, United States
• San Diego Imaging SDI — Chula Vista, California, United States
• Sharp Coronado Hospital — Coronado, California, United States
• Southern California Research Center — Coronado, California, United States
• Holy Trinity Medical Clinic — Harbor City, California, United States
• Innovative Clinical Research, Inc. — Harbor City, California, United States
• ICM Medical Group — Inglewood, California, United States
• eStudySite — La Mesa, California, United States
• Clinical Trials Research — Lincoln, California, United States
• National Research Institute — Los Angeles, California, United States
• Renaissance Imaging Medical Associates — Northridge, California, United States
• Huntington Medical Research Institute — Pasadena, California, United States
• Inland Empire Clinical Trials, LLC — Rialto, California, United States
• Diagnostic Radiological Imaging Sacramento — Sacramento, California, United States
• Precision Research Institute — San Diego, California, United States
• Sharp and Children's MRI Center, LLC — San Diego, California, United States
• Sharp & Children's MRI Center, LLC — San Diego, California, United States
• West Coast Radiology — Santa Ana, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Liberty Pacific Advanced Imaging — Tarzana, California, United States
• Advanced Gastroenterology — Thousand Oaks, California, United States
• Horizon Clinical Research Associates, PLLC — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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