Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Experimental
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo
Placebo administered SC once a week.
  • Drug: Placebo
    Administered SC

Recruiting Locations

University of Alabama at Birmingham Medical Center
Birmingham, Alabama 35233
Contact:
205-975-5683

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinicaltrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.