A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
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).
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)
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)
La Jolla, California 92037, United States
Ramat Gan, Central District 5265601, Israel
Haifa, Northern District 3109601, Israel
Nagakute-shi, Aichi-ken 480-1195, Japan
Higashi-cho, Hirakata-city, Osaka 573-0153, Japan
Bunkyō, Tokyo 113-8519, Japan
Cuautitlan Izcalli, Mexico City 54769, Mexico
Nottingham, Nottinghamshire NG7 2UH, United Kingdom
Stockton-on-Tees, Stockton-on-Tees TS19 8PE, United Kingdom