A Study of Tirzepatide (LY3298176) in Participants 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).
The study will last about 68 weeks and may include up to 15 visits.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of 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 the participant has T2DM, the hemoglobin A1c (HbA1c) ≤9.5%
-Participants must be willing to undergo baseline and endpoint liver biopsies
-Participants must have a liver biopsy that shows fatty liver with liver scarring
-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 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 a diagnosis of type 1 diabetes
-Participants must not have a history of inflammation of the pancreas
-Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate birth control