Last updated on October 2020

A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-alcoholic Fatty Liver Disease | Nonalcoholic Steatohepatitis | Nonalcoholic Steatohepatitis (NASH)
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

  • Participants must have a body mass index (BMI) 27 kilograms per square meter (kg/m) and 50 kg/m 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/1.73m; for participants on metformin, eGFR <45 mL/min/1.73m
    • 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)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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