Claimed effect · Pemvidutide

Does Pemvidutide help with MASH resolution without worsening fibrosis?

B
Grade B — probable, not settled1 phase 2b RCT (n=212, 24 wk) · effect size: large
Short answerProbable, not settled. Human data exist (1 phase 2b RCT (n=212, 24 wk)) and mostly agree, showing a large effect — but too few, too small, or not yet peer-reviewed for a firm answer. IMPACT randomised 212 patients with biopsy-confirmed MASH and F2–F3 fibrosis to one of two weekly doses or placebo for 24 weeks. Resolution without fibrosis worsening reached 58% and 52% against 20% on placebo — differences of 38 and 32 percentage points, both highly significant, on paired biopsies.

What the studies show

IMPACT randomised 212 patients with biopsy-confirmed MASH and F2–F3 fibrosis to one of two weekly doses or placebo for 24 weeks. Resolution without fibrosis worsening reached 58% and 52% against 20% on placebo — differences of 38 and 32 percentage points, both highly significant, on paired biopsies.

“MASH resolution without fibrosis worsening was observed in 18 (20%) of 86 patients in the placebo group, 24 (58%) of 41 patients in the 1·2 mg pemvidutide group (difference of 38% [95% CI 21-56]; p<0·0001), and 45 (52%) of 85 patients in the 1·8 mg pemvidutide group (difference of 32% [95% CI 19-46]; p<0·0001).”

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 MASH resolution without worsening fibrosis?
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?
IMPACT randomised 212 patients with biopsy-confirmed MASH and F2–F3 fibrosis to one of two weekly doses or placebo for 24 weeks. Resolution without fibrosis worsening reached 58% and 52% against 20% on placebo — differences of 38 and 32 percentage points, both highly significant, on paired biopsies.
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 →