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Pemvidutide

DRUG5 trials

Sponsors

Altimmune, Inc.

Conditions

Alcohol Use Disorder (AUD)Alcohol-associated Liver DiseaseMetabolic Dysfunction-Associated Steatohepatitis (MASH)NASH - Nonalcoholic SteatohepatitisNon-Alcoholic Steatohepatitis (NASH)

Phase 1

Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
CompletedNCT04972396
Altimmune, Inc.NASH - Nonalcoholic Steatohepatitis
Start: 2021-09-15End: 2022-05-15Updated: 2025-06-24

Phase 2

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
CompletedNCT05989711
Altimmune, Inc.Non-Alcoholic Steatohepatitis (NASH)
Start: 2023-07-27End: 2025-11-25Updated: 2026-05-18
RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
CompletedNCT06987513
Altimmune, Inc.Alcohol Use Disorder (AUD)
Start: 2025-05-15End: 2026-07-30Updated: 2026-07-31
RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Active, not recruitingNCT07009860
Altimmune, Inc.Alcohol-associated Liver Disease
Start: 2025-06-16End: 2027-09-30Updated: 2026-08-17

Phase 3

Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
RecruitingNCT07795164
Altimmune, Inc.Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Start: 2026-07-30End: 2032-12-01Target: 1800Updated: 2026-08-31

Related Papers

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.
2025-11-111 citations