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

• Status: Recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

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).

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tirzepatide

Criteria

• 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)