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# Altimmune Mixed Results for Pemvidutide in MASH
- URL: https://www.fdaweb.com/altimmune-mixed-results-for-pemvidutide-in-mash/
- Published: 2025-06-26T12:00:00.000Z
- Updated: 2026-09-14T15:15:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159422

Altimmune is announcing mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease. The study showed that pemvidutide led to significant improvements in disease resolution and weight loss, with promising signals of anti-fibrotic activity, according to the company.

However, the drug’s effects on fibrosis improvement without worsening of MASH were 31.8% and 34.5% for pemvidutide 1.2 mg and 1.8 mg, respectively, compared with 25.9% for placebo — differences that the company says were not statistically significant. But a supplemental AI-based analysis “demonstrated statistically significant reductions in fibrosis, including 30.6% of participants receiving pemvidutide 1.8 mg achieving a 60% or more reduction in fibrosis compared to 8.2% receiving placebo,” it says.

The 24-week study enrolled 212 patients with biopsy-confirmed MASH and moderate to advanced fibrosis (stages F2/F3), including those with and without diabetes. The company says participants were randomized to receive once-weekly subcutaneous injections of pemvidutide at either 1.2 mg or 1.8 mg, or a placebo. According to an intent-to-treat (ITT) analysis, 59.1% of patients receiving 1.2 mg and 52.1% receiving 1.8 mg of pemvidutide achieved resolution of MASH without worsening of fibrosis, it says. By contrast, only 19.1% of patients in the placebo group achieved the same outcome, a statistically significant difference.

Beyond liver outcomes, pemvidutide produced notable weight loss: 5.0% and 6.2% reductions in body weight in the 1.2 mg and 1.8 mg groups, respectively, compared with just 1.0% for placebo, Altimmune says. Liver fat levels also fell by 58.0% and 62.8% with pemvidutide, versus a 16.2% reduction in the placebo group.