A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: November 19, 2019
End Date: March 21, 2022
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
1-317-615-4559
- 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)
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Conditions:
- Fatty Liver
- Non-alcoholic Fatty Liver Disease