Phase 2
Completed N=190
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
Source: ClinicalTrials.gov NCT04166773 ↗Enrolled (actual)
190
Serious AEs
6.3%
Results posted
Jan 2025
Primary outcomePrimary: Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology — 51.84; 63.13; 73.92; 12.62 Percentage of participants — p=<0.001
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology |
51.84; 63.13; 73.92; 12.62 | <0.001 sig |
| SECONDARY Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology |
59.21; 53.35; 54.3; 32.51 | 0.025 sig |
| SECONDARY Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology |
12.04; 9.81; 5.53; 13.03 | 0.893 |
| SECONDARY Percentage of Participants That Achieve a ≥2 Point Decrease in NAFLD (Non-alcoholic Fatty Liver Disease) Activity Score (NAS) on Liver Histology, With ≥1 Point Reduction in at Least 2 NAS Components |
81.02; 86.55; 88.77; 38.09 | <0.001 sig |
| SECONDARY Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) |
-10.12; -10.15; -11.34; -1.31 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Body Weight |
-11.46; -14.22; -17.88; -1.04 | <0.001 sig |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT04166773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.