TRIUMPH-MASH: Retatrutide in Metabolic Dysfunction-Associated Steatohepatitis
NCT05765604 · Eli Lilly
- Phase
- Phase 3
- Enrollment
- 700 participants
- Est. completion
- Q1 2027
- Sponsor
- Eli Lilly
Background
TRIUMPH-MASH evaluates retatrutide in adults with biopsy-confirmed MASH (metabolic dysfunction-associated steatohepatitis, formerly NASH) and significant fibrosis. The glucagon receptor agonism of retatrutide is hypothesized to provide additional hepatic benefit beyond GLP-1/GIP agonism alone by promoting hepatic fat oxidation and reducing hepatic glucose output. Phase 2 data showed significant reductions in liver fat by MRI-PDFF and improvements in liver enzymes.
Primary endpoint
NASH resolution without worsening of fibrosis at 48 weeks (liver biopsy)
Secondary endpoints
- Improvement in fibrosis by ≥ 1 stage without worsening of NASH
- Change in liver fat content by MRI-PDFF
- Change in ALT and AST
- Change in body weight
- Change in liver stiffness by elastography
Population
Adults with biopsy-confirmed NASH (MAFLD) and fibrosis stage F2–F3, with or without type 2 diabetes
Intervention
Retatrutide 8 mg or 12 mg SC once weekly vs. placebo; dose escalation over 20 weeks
Inclusion criteria
Adults ≥ 18 years; biopsy-confirmed NASH with NAS ≥ 4 and fibrosis stage F2–F3; ALT > 1.5× ULN; BMI ≥ 25 kg/m²
Exclusion criteria
Cirrhosis (F4 fibrosis); alcohol consumption > 21 units/week (men) or > 14 units/week (women); other causes of liver disease; decompensated liver disease
Trial information sourced from ClinicalTrials.gov and published literature. TryTrutide is not affiliated with Eli Lilly or any trial site. This is not medical advice.