Summary

for people ages 18-80 (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).

Official Title

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

Keywords

Nonalcoholic Steatohepatitis Fatty Liver Non-alcoholic Fatty Liver Disease Tirzepatide

Eligibility

For people ages 18-80

  • Participants must have a body mass index (BMI) ≥27 kilograms per square meter (kg/m²) and ≤50 kg/m² with stable body weight for at least 3 months
  • Participants with or without type 2 diabetes mellitus (T2DM)
  • If with T2DM, hemoglobin A1c (HbA1c) ≤9.5%
  • Participants must be willing to undergo baseline and endpoint liver biopsies
  • Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by liver biopsy
  • Participants must not have known or suspected alcohol abuse (>14 units/week for women and >21 units/week for men) or active substance abuse
  • Participants must not have evidence of cirrhosis or other forms of liver disease
  • Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 6 months
  • Participants must not have active cancer within the last 5 years
  • Participants must not have uncontrolled high blood pressure
  • Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <30 milliters/minute/1.73m²; for participants on metformin, eGFR <45 mL/min/1.73m²
  • Participants must not have a diagnosis of type 1 diabetes
  • Participants must not have a history of pancreatitis (acute or chronic)
  • Participants must not have calcitonin ≥35 nanograms per liter
  • Participant must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
  • Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Locations

  • NAFLD Research Center, UCSD Altman Clinical and Translational Research Institute (ACTRI) not yet accepting patients
    La Jolla California 92037 United States
  • Catalina Research Institute, LLC not yet accepting patients
    Montclair California 91763 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
ID
NCT04166773
Phase
Phase 2
Study Type
Interventional
Last Updated