Study S000412

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05989711
Acronym: IMPACT
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 212
Start: 2023-07-27
Primary completion: 2025-11-25
Lead sponsor: Altimmune, Inc.
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Interventions: DRUG:Pemvidutide; DRUG:Placebo
Results posted: FALSE

Registered primary outcomes

Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis [24 weeks]
Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis) [24 weeks]
Incidence of Treatment Emergent Adverse Events [52 weeks]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0011391	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. Noureddin M, Lancet (London, England)	2025	Randomized trial	PMID 41237796 DOI	cites ClinicalTrials.gov:NCT05989711; registry reference DERIVED:41237796
R0038882	2025 Late Breaking Abstracts , Hepatology	2025	Randomized trial	PMID 41201154 DOI	cites ClinicalTrials.gov:NCT05989711