A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Overview
- Phase
- Phase 2
- Intervention
- Tirzepatide
- Conditions
- Nonalcoholic Steatohepatitis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 190
- Locations
- 108
- Primary Endpoint
- Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Intervention: Tirzepatide
10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Intervention: Tirzepatide
15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Intervention: Tirzepatide
Placebo
Placebo administered SC once a week.
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology
Time Frame: Week 52
NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52.
Secondary Outcomes
- Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology(Week 52)
- Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology(Week 52)
- 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(Week 52)
- Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)(Baseline to Week 52)
- Mean Change From Baseline in Body Weight(Baseline to Week 52)