Pemvidutide heads to AASLD with liver-marker results beyond its early biopsies

Altimmune announced on October 19 that it will present a new analysis of pemvidutide’s 48-week liver results on November 8 at the American Association for the Study of Liver Diseases (AASLD) meeting. The analysis will examine whether several measures improve in the same participants, following IMPACT’s earlier biopsy findings.[1]

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An update to an existing trial

Pemvidutide is an investigational peptide that activates receptors for glucagon and glucagon-like peptide-1, or GLP-1. Altimmune, its developer, says the presentation will examine simultaneous improvements in liver stiffness, blood markers and liver fat.[1]

The timing matters. Altimmune disclosed IMPACT’s first 48-week results in December 2025. The forthcoming presentation will examine responses within that trial, rather than introduce a newly completed study. The December update included blood and imaging measures intended to track liver disease without taking another tissue sample.[3]

IMPACT (NCT05989711) enrolled 212 participants with metabolic dysfunction-associated steatohepatitis, or MASH, and moderate to advanced liver scarring. The randomized phase 2b trial, a midstage study, compared pemvidutide with placebo, with its main biopsy assessment at 24 weeks.[2][5]

MASH involves fatty liver disease with inflammation and cell injury. The scarring is called fibrosis.[4]

What the earlier biopsies found

The biopsy results asked two different questions. Had MASH resolved without fibrosis getting worse? And had fibrosis improved without MASH getting worse? Improvement in one endpoint did not require improvement in the other.[2]

The Altimmune-funded study’s 24-week results, published in The Lancet, showed a statistically significant advantage over placebo for MASH resolution without worsening fibrosis. The separate endpoint of fibrosis improvement without worsening MASH did not reach statistical significance. That leaves an important distinction between reducing the active disease process and demonstrating a change in the scar tissue already present.[2]

Biopsies examine tissue directly, while the later blood and imaging measurements capture related features of disease. A stronger result in those measurements would add evidence about the treatment response, but it would not turn the earlier fibrosis endpoint into a positive one.[2][3]

Why the measurements can move differently

Elastography measures liver stiffness. Scarring can raise the reading, but so can inflammation and congestion, or excess blood accumulating in the liver. A fall therefore has more than one possible explanation.[4]

The Enhanced Liver Fibrosis test, usually shortened to ELF, measures blood markers associated with the turnover of the material that forms scar tissue. Liver fat imaging measures a different feature again. Alanine aminotransferase, or ALT, is a blood enzyme marker used to follow liver injury. These tests can move together while describing different parts of the response.[4]

The question for November

A responder analysis can show whether improvements occur together in individual participants. Separate group averages cannot answer whether the same people improve across several measures. Altimmune says the November analysis will examine combined responses against placebo.[1]

The response thresholds and the number of participants with evaluable measurements will show how broad that pattern is. Missing results matter: an analysis restricted to people with complete measurements may describe a smaller, selected group. Whether the comparison was planned in advance will also help readers judge how much weight to give it.[1][3]

The benefit question also has a tolerability side. Altimmune’s 48-week update reported adverse events that led some participants to stop treatment. A separate November 7 poster will examine gastrointestinal tolerability, including digestive side effects. These are company-reported findings from a midstage study, not a complete account of longer-term risk.[1][3]

Altimmune plans to post the presentation materials after the meeting. The November analysis could show how consistently different signs of liver disease respond over time. Demonstrating that scar tissue has receded still requires evidence linking those changes to tissue findings and later health outcomes.[1][4]