A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (SYNERGY-NASH)

Lilly

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04166773

I8F-MC-GPHR (Other Identifier)

17361

2019-001550-26 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 196 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

196 participants in 4 patient groups, including a placebo group

5 mg Tirzepatide

Experimental group

Description:

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

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

10 mg tirzepatide administered SC once a week.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

15 mg tirzepatide administered SC once a week.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC once a week.

Treatment:

Drug: Placebo