At a glance
| Development code | ALT-801 |
|---|---|
| Targets | GLP-1 and glucagon receptors |
| Studied route | Subcutaneous injection |
| Liver program | IMPACT phase 2b |
| Key distinction | MASH resolution versus fibrosis improvement |
Overview
Pemvidutide, formerly ALT-801, is designed to combine GLP-1 and glucagon receptor activity. Its liver program distinguishes fat reduction, resolution of steatohepatitis and improvement in scarring because these are related but different outcomes. IMPACT enrolled patients with biopsy-confirmed MASH and moderate-to-advanced fibrosis. The published interim analysis supports activity against MASH, while the negative fibrosis comparison remains important. Marketing language that says a peptide 'reverses fatty liver' can obscure these distinctions, the investigational status and the need for longer follow-up to evaluate clinical consequences.
How it works
GLP-1 signaling influences appetite and glucose regulation, while glucagon receptor activity changes hepatic metabolism and can increase energy expenditure. The combined design aims to reduce body weight and liver fat without losing glycemic control. Reduced hepatic fat may contribute to improvement in inflammation, but remodeling established fibrosis is a separate biological process and must be measured directly rather than assumed from weight loss.
Who was studied
IMPACT enrolled 212 patients with biopsy-confirmed MASH and stage F2 or F3 fibrosis. It did not establish treatment for all causes of elevated liver enzymes, all degrees of fibrosis or decompensated cirrhosis.
Supporting sources [1]
Positive MASH endpoint
At twenty-four weeks, MASH resolution without worsening fibrosis occurred in 58% and 52% of the two active groups versus 20% with placebo. The prespecified analysis supported a treatment effect on that endpoint.
Supporting sources [1]
Fibrosis result was different
Fibrosis improvement without worsening MASH occurred in 33% and 36% of the active groups versus 28% with placebo; neither comparison was statistically significant. The study therefore did not meet both primary endpoints at the reported time point.
Supporting sources [1]
Tolerability and remaining uncertainty
Most adverse events were mild or moderate, and discontinuation because of adverse events was uncommon in the reported study. Longer exposure and larger populations remain necessary to characterize rare harms and the clinical importance of histologic changes.
Supporting sources [1]
Why several liver measures are needed
Body weight, imaging-derived liver fat, liver enzymes, inflammation and fibrosis answer different questions. Earlier metabolic studies support development, but a favorable change in one measure cannot be substituted for proven reduction in liver failure, transplantation or mortality.
Reading this profile
Jurisdiction: Investigational; no FDA-approved pemvidutide medicine identified as of 2026-10-27.. Molecular class: Dual GLP-1 and glucagon receptor agonist peptide.
This profile was written with AI-assisted research and checked against the linked sources. It has not been represented as a clinician’s review. Evidence summaries describe the cited studies and products; they do not establish that a separately purchased preparation is equivalent.
Sources & references
Follow the original material. Product labels define specific formulations and uses; trial registration describes a study and does not by itself establish benefit.
- 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. ↗Original research · Checked 2026-10-27
- Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. ↗Original research · Checked 2026-10-27
- ClinicalTrials.gov: Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH ↗Clinical trial source · Checked 2026-10-27