Claimed effect · Pemvidutide

Does Pemvidutide help with fibrosis improvement?

B
Grade B — probable, not settled1 phase 2b RCT (n=212, 24 wk) · effect size: not measurable
Short answerProbable, not settled. Human data exist (1 phase 2b RCT (n=212, 24 wk)) and mostly agree, showing no measurable effect, or none yet shown — but too few, too small, or not yet peer-reviewed for a firm answer. The other half of the result, and the part that matters most for liver outcomes: fibrosis improvement without worsening of MASH was no better than placebo at either dose, with confidence intervals crossing zero. Twenty-four weeks is short for fibrosis to change, which is the sponsor's explanation and remains an explanation rather than a finding.

What the studies show

The other half of the result, and the part that matters most for liver outcomes: fibrosis improvement without worsening of MASH was no better than placebo at either dose, with confidence intervals crossing zero. Twenty-four weeks is short for fibrosis to change, which is the sponsor's explanation and remains an explanation rather than a finding.

“Fibrosis improvement without worsening of MASH was observed in 24 (28%) of 86 patients in the placebo group, 13 (33%) of 41 patients in the 1·2 mg pemvidutide group (difference of 5% [95% CI -13 to 22]; p=0·59), and 30 (36%) of 85 patients in the 1·8 mg pemvidutide group (difference of 8% [95% CI -6 to 22]; p=0·27).”

Verbatim, from the abstractNoureddin M, et al. Pemvidutide, a GLP-1/glucagon dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (IMPACT): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet, 2025

Human trials exist and mostly agree, but there are too few of them, they are too small, or one big one is still reading out. Expect the grade to move.

  1. 1
    Noureddin M, et al. Pemvidutide, a GLP-1/glucagon dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (IMPACT): a randomised, double-blind, placebo-controlled, phase 2b trial.Lancet, 2025212 randomised, biopsy-confirmed MASH with F2–F3 fibrosis, 24 weeks. NCT05989711. Resolution endpoint met; fibrosis endpoint not met.

In context

Pemvidutide is a once-weekly peptide agonist at both the GLP-1 and glucagon receptors, developed by Altimmune for metabolic dysfunction-associated steatohepatitis (MASH). In IMPACT, a 212-patient phase 2b published in The Lancet in 2025, MASH resolved without worsening of fibrosis in 52–58% of treated patients against 20% on placebo at 24 weeks. The second endpoint — fibrosis improvement — was not met at either dose. It is not approved anywhere.

Pemvidutide is investigational (phase 2b). Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is Pemvidutide proven to help with fibrosis improvement?
Not yet settled. 1 phase 2b RCT (n=212, 24 wk) — LYO grades it B, meaning probable but liable to change as trials read out.
What studies are behind the grade?
The other half of the result, and the part that matters most for liver outcomes: fibrosis improvement without worsening of MASH was no better than placebo at either dose, with confidence intervals crossing zero. Twenty-four weeks is short for fibrosis to change, which is the sponsor's explanation and remains an explanation rather than a finding.
Is Pemvidutide approved for this?
No. Pemvidutide is investigational (phase 2b); it is not an approved medicine for any indication in the jurisdictions LYO covers.

Other outcomes for Pemvidutide

Written and maintained by LYO Research — how pages are written and checked. Reviewed 29 October 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →