IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)

NCT05989711 ↗

Phase 2 Completed 212 enrolled Altimmune, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

Timeline

Start: 2023-07-27
Primary completion: 2025-11-25
Completion: 2025-11-25

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper Pemvidutide treatment met the primary endpoint of MASH resolution without worsening of fibrosis at 24 weeks reads as mixed primary results PMID 41237796 ↗

paper but did not meet the other primary endpoint of fibrosis improvement without worsening of MASH at this timepoint. reads as mixed primary results PMID 41237796 ↗

release “achieved statistically significant MASH resolution without worsening of fibrosis” reads as met primary endpoint altimmune.com ↗

Publications

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. 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. Lancet. 2025 Dec 6;406(10520):2644-2655. doi: 10.1016/S0140-6736(25)02114-2. Epub 2025 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pemvidutide	Unknown	1.2 mg	Subcutaneous
Subject	Pemvidutide	Unknown	1.8 mg	Subcutaneous