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

NCT05989711 · Completed

Last updated 2026-05-28

This clinical trial is testing the drug pemvidutide in adults with nonalcoholic steatohepatitis (NASH) to see if it can improve liver inflammation and damage.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 212 people

Who can join Ages 18–75 · all sexes

Timeline Started 2023-07 · est. completion 2025-11

Where 40 sites · Australia, Puerto Rico, United States

What this study is testing ClinicalTrials.gov NCT05989711 ↗

Description as written by the study sponsor.

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

Treatments tested

Pemvidutide Drug

Administered once weekly by subcutaneous injection
Placebo Drug

Administered once weekly by subcutaneous injection

Main thing measured	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
Sponsor	Altimmune, Inc.
Conditions studied	Non-Alcoholic Steatohepatitis (NASH)
GLP-1 drugs	pemvidutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05989711 ↗