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Pipeline › pemvidutide

pemvidutide

Not FDA-approved, and in phase 2 development, not authorised in the European Union. 2 active trials, the next due to complete 2027-09-30.

GLP-1/glucagon agonist, SC, from Altimmune. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.

Status
phase2
Target
GLP-1/glucagon
Route
SC
Sponsor
Altimmune
First FDA approval
Not approved
EU authorisation
Not authorised
Active trials
2 (1 in phase 3)
Participants enrolled
1,921
Trials with a reporting date
2
Approved FDA submissions
0

Recent changes

DetectedChangeTrialDetailPhase
2026-08-31New trial registeredPhase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
NCT07795164 · Altimmune, Inc.
Recruiting, n=1,800P3

When these trials report

01Q3 26: 0 trials reportingQ4 26: 0 trials reportingQ1 27: 0 trials reportingQ2 27: 0 trials reportingQ3 27: 1 trial reportingQ4 27: 0 trials reportingQ1 28: 0 trials reportingQ2 28: 0 trials reportingQ3 26Q4 26Q1 27Q2 271Q3 27Q4 27Q1 28Q2 28
When trials are due to report, by quarter — hover a bar for the count. These dates are filed by the sponsor and often move.

Next 2 of 2 active trials by estimated primary completion.

Est. completionTrialSponsorPhaseParticipants
2027-09-30RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
NCT07009860 · Relative (%) reduction in liver stiffness by VCTE compared to baseline
Altimmune, Inc.P2121
2028-12Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
NCT07795164 · Clinical Outcome Event
Altimmune, Inc.P31,800

Indications under study

Alcohol-associated Liver Disease; Metabolic Dysfunction-Associated Steatohepatitis (MASH).

Recent papers

PublishedTitleJournal
2026-03-25Efficacy and safety of pemvidutide in metabolic dysfunction-associated steatohepatitis: a GRADE-assessed meta-analysis of randomized controlled trials
Rajab I, Emara A, Rakab MS, Azim AAA, Aboeldahab H, Abbas OF, Rahman RA, Karagozian R.
Naunyn Schmiedebergs Arch Pharmacol
2025-12-23Efficacy and Safety of Pemvidutide in Patients with Metabolic Dysfunction-Associated Steatohepatitis: A Systematic Review and Dose-Specific Meta-Analysis of Randomized Controlled Trials
Abdu E, Alghamdi R, Mohsen A, Alabbad Z, Kharabah M, Al-Thagfi A, Al-Shabeeb M, Alanzi F, Al-Harthi H, Alessa A, Al-Murdhimah A.
medRxiv preprint
2025-12-01The dual GLP-1-glucagon agonist pemvidutide in MASH: a phase 2b trial
Tacke F.
Lancet
2025-11-11Safety 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
Noureddin M, Harrison SA, Loomba R, Alkhouri N, Chalasani N, Sheikh MY, Tomah S, Gutierrez JA, Urbina S, Suschak JJ, Brown R, Odili O, Yang J, Keeton S, Neff G, Mena E, Roberts MS, Browne SK, Harris MS.
Lancet
2025-06-18Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial
Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Georges B, Roberts MS, Harris MS.
JHEP Rep
2024-07-11Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study
Harrison SA, Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Roberts MS, Harris MS.
J Hepatol

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