Tirzepatide for Non-alcoholic Fatty Liver Disease
(SYNERGY-NASH Trial)

Recruiting in Palo Alto (17 mi)

+233 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if a medication called tirzepatide, taken regularly, is safe and effective for people with Nonalcoholic Steatohepatitis (NASH). NASH is a liver condition that can be hard to treat. Tirzepatide helps control blood sugar and reduce fat in the liver, which may improve liver health. Tirzepatide has shown effectiveness in treating obesity and diabetes.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with Nonalcoholic Steatohepatitis (NASH) who have a BMI of 27-50, stable weight for the past 3 months, and if diabetic, controlled HbA1c levels. They must not have had recent severe cardiovascular events or active cancer in the last 5 years and should be willing to undergo liver biopsies.

Inclusion Criteria

Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by liver biopsy

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

If with T2DM, hemoglobin A1c (HbA1c) ≤9.5%

See 2 more

Exclusion Criteria

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)

Participants must not have a diagnosis of type 1 diabetes

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)

See 8 more

Treatment Details

Interventions

Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist)

Trial OverviewThe study tests Tirzepatide's safety and effectiveness against NASH. Participants will receive either Tirzepatide or a placebo once weekly. The trial includes people with varying stages of fibrosis due to NASH, some may also have type 2 diabetes.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 5 mg TirzepatideExperimental Treatment1 Intervention

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

Group II: 15 mg TirzepatideExperimental Treatment1 Intervention

15 mg tirzepatide administered SC once a week.

Group III: 10 mg TirzepatideExperimental Treatment1 Intervention

10 mg tirzepatide administered SC once a week.

Group IV: PlaceboPlacebo Group1 Intervention

Placebo administered SC once a week.