The Investor
09 Nov 2026, 19:19
Merck Reports Positive Phase 2b Results for Efinopegdutide in MASH
Merck (NYSE: MRK) reported positive Phase 2b results for efinopegdutide, an investigational once-weekly GLP-1/glucagon receptor co-agonist being developed for adults with metabolic dysfunction-associated steatohepatitis, or MASH, and stage F2-F3 fibrosis.
The study met its primary endpoint, with MASH resolution without worsening of fibrosis achieved by 56%, 63% and 61% of patients receiving the 4 mg, 7 mg and 10 mg doses, respectively, compared with 13% for placebo at Week 52.
Efinopegdutide also showed improvement on the key secondary fibrosis endpoint. At least a one-stage improvement in fibrosis without worsening of steatohepatitis was seen in 43% of patients on 4 mg, 52% on 7 mg and 34% on 10 mg, versus 21% with placebo.
The safety profile was generally consistent with semaglutide, with gastrointestinal events including nausea, diarrhea and vomiting among the most common adverse effects. Discontinuation rates due to adverse events were 3%, 4% and 11% across the three efinopegdutide dose groups.
The Phase 2b trial enrolled 386 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis. Efinopegdutide has also received FDA Fast Track designation for the treatment of MASH.
The results strengthen Merck’s cardiometabolic pipeline by showing both disease-resolution and fibrosis benefits, although the program remains investigational and will require further development before any potential regulatory approval.
Merck (NYSE: MRK) reported positive Phase 2b results for efinopegdutide, an investigational once-weekly GLP-1/glucagon receptor co-agonist being developed for adults with metabolic dysfunction-associated steatohepatitis, or MASH, and stage F2-F3 fibrosis.
The study met its primary endpoint, with MASH resolution without worsening of fibrosis achieved by 56%, 63% and 61% of patients receiving the 4 mg, 7 mg and 10 mg doses, respectively, compared with 13% for placebo at Week 52.
Efinopegdutide also showed improvement on the key secondary fibrosis endpoint. At least a one-stage improvement in fibrosis without worsening of steatohepatitis was seen in 43% of patients on 4 mg, 52% on 7 mg and 34% on 10 mg, versus 21% with placebo.
The safety profile was generally consistent with semaglutide, with gastrointestinal events including nausea, diarrhea and vomiting among the most common adverse effects. Discontinuation rates due to adverse events were 3%, 4% and 11% across the three efinopegdutide dose groups.
The Phase 2b trial enrolled 386 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis. Efinopegdutide has also received FDA Fast Track designation for the treatment of MASH.
The results strengthen Merck’s cardiometabolic pipeline by showing both disease-resolution and fibrosis benefits, although the program remains investigational and will require further development before any potential regulatory approval.
