Merck Announces Positive Results from Phase 2b Trial of Efinopegdutide in Adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Stage 2-3 Fibrosis
Key Highlights
- ➤Efinopegdutide achieved MASH resolution in 56%-63% versus 13% for placebo at 52 weeks
- ➤Fibrosis improvement reached 52% with efinopegdutide 7 mg versus 21% for placebo
- ➤Trial enrolled 386 adults with biopsy-confirmed MASH and stage F2-F3 fibrosis
- ➤Efinopegdutide discontinuations due to adverse events reached 11% at the 10 mg dose
- ➤Efinopegdutide received FDA Fast Track designation for MASH treatment
Expert Statements
Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories
“MASH poses a substantial risk of progression to cirrhosis and ultimately liver failure, underscoring the urgent need for new treatment options”
Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories
“We are highly encouraged by these results which add to the evidence that efinopegdutide, a distinct GLP-1/glucagon receptor co-agonist, has the potential to provide clinically meaningful responses for MASH resolution and fibrosis regression.”
Jӧrn M. Schattenberg, Professor, Department of Internal Medicine II, Saarland University Medical Center
“MASH is a chronic inflammatory liver disease, with limited treatment options. Achieving disease resolution establishes an important treatment goal.”
Jӧrn M. Schattenberg, Professor, Department of Internal Medicine II, Saarland University Medical Center
“The improvements observed in fibrosis grading following efinopegdutide treatment in this study are notable and underscore its potential as a therapeutic option in patients with MASH and fibrosis.”
Merck Announces Positive Results from Phase 2b Trial of Efinopegdutide in Adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Stage 2-3 Fibrosis
Efinopegdutide demonstrated a statistically significant greater proportion of participants achieved MASH resolution without worsening of fibrosis versus placebo at 52 weeks
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