A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (SYNERGY-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).
Trial Summary
Key Requirements
Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.Participants Must:
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:
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
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Clinical Trial Resources
You will complete the questionnaire on another website.YesNo