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Pemvidutide: Trials and FDA Status

Pemvidutide is a glp-1/glucagon dual agonist. 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 3 (MASH)
Sponsor
Altimmune
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT05989711, NCT07795164
Results

Reported results

  • 2025IMPACT phase 2b (Lancet 2025): MASH resolution without fibrosis worsening at 24 weeks“MASH resolution without fibrosis worsening was observed in 18 (20%) of 86 patients in the placebo group, 24 (58%) of 41 patients in the 1·2 mg pemvidutide group (difference of 38% [95% CI 21-56]; p<0·0001)”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. NCT07795164 (PERFORMA; Phase 3): primary completion (estimated)
  2. NCT07795164 (PERFORMA; Phase 3): first posted on ClinicalTrials.gov
  3. Altimmune reports initiation of the global PERFORMA phase 3 MASH trial
  4. NCT07795164 (PERFORMA; Phase 3): study start
  5. Altimmune reports FDA Breakthrough Therapy Designation for pemvidutide in MASH
  6. NCT05989711 (IMPACT; Phase 2): primary completion
  7. Published in Journal of hepatology (2025): Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study.
  8. Published in JHEP reports : innovation in hepatology (2025): Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial.
  9. Published in Lancet (London, England) (2025): Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study.
  10. NCT05989711 (IMPACT; Phase 2): first posted on ClinicalTrials.gov
  11. NCT05989711 (IMPACT; Phase 2): study start

What people search

  • pemvidutide phase 340/mo
  • pemvidutide fda approval10/mo
  • pemvidutide clinical trial10/mo

US monthly searches, Google Keyword Planner, Oct 2026. Shown so you can see which questions this page answers.

Sources

  1. 1IMPACT: IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (NCT05989711)ClinicalTrials.gov (U.S. National Library of Medicine) · 2023clinicaltrials.govAccessed 2 Oct 2026
  2. 2PERFORMA: Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH (NCT07795164)ClinicalTrials.gov (U.S. National Library of Medicine) · 2026clinicaltrials.govAccessed 2 Oct 2026
  3. 3Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study.Journal of hepatology · 2025PMID 39002641Accessed 2 Oct 2026
  4. 4Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial.JHEP reports : innovation in hepatology · 2025PMID 41113119Accessed 2 Oct 2026
  5. 5Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study.Lancet (London, England) · 2025PMID 41237796Accessed 2 Oct 2026
  6. 6Altimmune reports FDA Breakthrough Therapy Designation for pemvidutide in MASHAltimmune (press release) · 2026sec.govAccessed 2 Oct 2026
  7. 7Altimmune reports initiation of the global PERFORMA phase 3 MASH trialAltimmune (press release) · 2026sec.govAccessed 2 Oct 2026

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