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

What Was Tested

This registered phase 2 trial tested Pemvidutide.

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

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 212 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent. Male or female 18-75 years. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation. Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: history or clinical evidence of type 1 diabetes mellitus; liver conditions:; history of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Pemvidutide and who got the comparison, which limits bias.

The Pemvidutide group and the comparison group ran side by side rather than switching.

As a double-blind Pemvidutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-07-27 with completion listed for 2025-11-25.

It ran at 40 sites in United States (29), Australia (10) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of Treatment Emergent Adverse Events (time frame: 52 weeks).

It also tracked 13 secondary outcomes, for example Relative change (%) in liver fat content by MRI-PDFF, Absolute change in MRI-based corrected T1 (cT1) imaging, Absolute change in alanine aminotransferase (ALT), Absolute change in Enhanced Liver Fibrosis (ELF) score, Absolute change in Fibroscan-AST (FAST) score and Relative (%) change in body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pemvidutide in 212 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pemvidutide compound page, all human trials.