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

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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

Trial contacts and locations

114

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Data sourced from clinicaltrials.gov

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