Merck & Co., Inc. (NYSE: MRK) announced on Tuesday, November 10, 2026, that comprehensive results from its Phase 2b clinical trial evaluating investigational efinopegdutide (MK-6024) have been published in The Lancet and presented during a late-breaking session at The Liver Meeting in Chicago. The trial demonstrated that the dual GLP-1 and glucagon receptor co-agonist produced a statistically significant 63 percent resolution rate of metabolic dysfunction-associated steatohepatitis (MASH) without worsening of fibrosis in adult patients following 52 weeks of once-weekly treatment. Phase 2b MK-6024-013 Clinical Trial Data Published in The Lancet The landmark medical publication details findings from the rigorous, randomized, double-blind, placebo-controlled MK-6024-013 study evaluating efinopegdutide across multiple clinical centers worldwide.
% MASH Resolution and 52% Fibrosis Improvement at 7 mg
The trial enrolled 381 adult patients with biopsy-confirmed MASH and stage F2 or F3 moderate-to-severe liver fibrosis. Participants were randomized to receive once-weekly subcutaneous injections of efinopegdutide at doses of 4 mg, 7 mg, or 10 mg, matching placebo, or an active reference arm receiving open-label semaglutide 2.4 mg. Over the 52-week treatment duration, 349 patients (92 percent) completed the study protocol. Histological assessments were conducted using the standardized Nonalcoholic Steatohepatitis Clinical Research Network scoring criteria via blinded independent central review, providing robust empirical proof of therapeutic efficacy.
The lead trial investigator and Professor of Medicine at Saarland University Medical Center stated during the scientific congress: "Metabolic dysfunction-associated steatohepatitis represents a severe chronic condition that has historically lacked targeted pharmacotherapies capable of resolving inflammation and reversing liver scarring. The compelling histological improvements documented in this trial highlight the transformative potential of dual GLP-1 and glucagon receptor co-agonism for patients with progressive liver disease." Achieving 63% MASH Resolution and 52% Fibrosis Improvement at 7 mg Dose The study achieved its primary and key secondary histological endpoints with exceptional statistical significance across evaluated therapeutic doses.
At Week 52, histological MASH resolution without worsening of fibrosis was achieved in 63 percent of patients receiving efinopegdutide 7 mg, 61 percent receiving 10 mg, and 56 percent receiving 4 mg, compared to only 13 percent in the placebo group (p<0.0001 for all comparisons). In the key secondary endpoint of liver fibrosis improvement by at least one stage without worsening of steatohepatitis, the 7 mg dose achieved a 52 percent response rate, significantly outperforming placebo's 21 percent and the semaglutide active reference arm's 25 percent. The dual-action mechanism demonstrated potent hepatic defatting and anti-fibrotic activity directly within diseased liver tissue.
Safety Profile and Global Phase 3 Plans for 2027
The Global Head of Clinical Development at Merck Research Laboratories commented in an interview: "Reversing liver fibrosis while eliminating active steatohepatitis represents the gold standard in hepatology. These remarkable Phase 2b histological results provide strong clinical validation as we accelerate preparations to advance efinopegdutide into global Phase 3 registrational studies." Demonstrating Tolerable Safety Profile Ahead of Global Phase 3 Registrational Program In addition to superior histological efficacy, the investigational therapy exhibited a manageable safety and tolerability profile consistent with the incretin drug class.
The most frequently reported adverse events were gastrointestinal in nature, including mild-to-moderate nausea, diarrhea, and vomiting, primarily occurring during the initial dose-escalation phase. Discontinuations due to adverse events occurred in only 4 percent of patients in the 7 mg cohort. Efinopegdutide has received Fast Track designation from the U.S. Food and Drug Administration, and Merck plans to initiate a global Phase 3 clinical development program in 2027 to support future regulatory filings.
A member of the American Association for the Study of Liver Diseases governing board observed: "The publication of these Phase 2b data in The Lancet marks an important scientific advance in cardiometabolic medicine. A dual-targeted therapy capable of delivering both MASH clearance and substantial fibrosis reversal addresses one of the most critical unmet needs in modern gastroenterology."
Advisors Note Predictable Frameworks and 2027 Milestones
Strategic planning advisors and international trade specialists noted that long-term intergovernmental frameworks generate predictable operating environments across key industry sectors. By coupling transparent administrative guidelines with rigorous scientific benchmarks, regulatory bodies and enterprise leaders establish sustainable operating models capable of withstanding shifting macroeconomic dynamics. Global market participants will continue observing forthcoming implementation milestones as public agencies execute their mandated responsibilities throughout 2027. Cross-border coordination remains vital for driving sustained operational resilience and delivering measurable societal benefits worldwide.
