Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Non-alcoholic Steatohepatitis Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Diabetes Mellitus Diabetes Mellitus, Type 2

Eligibility

You can join if…

Open to people ages 18-70

  • 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 CAN'T join 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

Locations

  • Harbor - UCLA Diagnostic Imaging Center not yet accepting patients
    Torrance California 90502 United States
  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center not yet accepting patients
    Torrance California 90502 United States
  • University Clinical Investigators, Incorporated accepting new patients
    Tustin California 92780 United States
  • Sharp and Children's MRI Center, LLC accepting new patients
    San Diego California 92123-2731 United States
  • Sharp & Children's MRI Center, LLC accepting new patients
    San Diego California 92123 United States
  • West Coast Radiology accepting new patients
    Santa Ana California 92705 United States
  • Liberty Pacific Advanced Imaging accepting new patients
    Tarzana California 91356 United States
  • National Research Institute accepting new patients
    Los Angeles California 90057 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT03969719
Phase
Phase 2
Study Type
Interventional
Last Updated