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Efinopegdutide: Trials and FDA Status

Efinopegdutide is a glp-1/glucagon dual agonist (mash). This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Investigational
Phase
Phase 2
Sponsor
Merck Sharp & Dohme
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT04944992, NCT05877547
Results

Reported results

  • 2023Phase 2a vs semaglutide in NAFLD (J Hepatol 2023): liver fat reduction at week 24“The least squares (LS) mean relative reduction from baseline in LFC at Week 24 was significantly (p <0.001) greater with efinopegdutide (72.7% [90% CI 66.8-78.7]) than with semaglutide (42.3% [90% CI 36.5-48.1])”pubmed.ncbi.nlm.nih.gov

Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.

Timeline

Milestones

  1. NCT05877547 (A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013); Phase 2): primary completion
  2. NCT05877547 (A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013); Phase 2): study start
  3. NCT05877547 (A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013); Phase 2): first posted on ClinicalTrials.gov
  4. Published in Journal of hepatology (2023): A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease.
  5. NCT04944992 (A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001); Phase 2): primary completion
  6. NCT04944992 (A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001); Phase 2): study start
  7. NCT04944992 (A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001); Phase 2): first posted on ClinicalTrials.gov

Sources

  1. 1A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001) (NCT04944992)ClinicalTrials.gov (U.S. National Library of Medicine) · 2021clinicaltrials.govAccessed 2 Oct 2026
  2. 2A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013) (NCT05877547)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  3. 3A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease.Journal of hepatology · 2023PMID 37355043Accessed 2 Oct 2026

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