Pemvidutide

Safety and Efficacy of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH) — IMPACT Phase 2b

IMPACT is a multicentre, randomised, double-blind, placebo-controlled Phase 2b study evaluating once-weekly subcutaneous pemvidutide (1.2 mg or 1.8 mg) versus placebo for 24 weeks in adults with biopsy-confirmed MASH and fibrosis stages F2/F3. Primary 24-week results published in The Lancet (2025, PMID 41237796): MASH resolution without fibrosis worsening was achieved in 58% (1.2 mg) and 52% (1.8 mg) versus 20% with placebo (p<0.0001). Fibrosis improvement of ≥1 stage achieved in 34.5% (1.8 mg) vs placebo. The FDA granted Breakthrough Therapy Designation for pemvidutide in MASH in January 2026. New 48-week extension data presented at EASL 2026 (May 2026) showed sustained and significant reductions in triglycerides and total cholesterol, improvements in weight, waist circumference, and blood pressure. Altimmune plans to initiate Phase 3 registration trial in MASH in 2026.

A Phase 2 Study to Evaluate the Safety and Efficacy of ALT-801 (Pemvidutide) in Adults With Obesity or Overweight — MOMENTUM

MOMENTUM is a randomised, double-blind, placebo-controlled Phase 2b study evaluating once-weekly subcutaneous pemvidutide at 1.2 mg, 1.8 mg, and 2.4 mg versus placebo in adults with obesity or overweight over 48 weeks. Results presented at ADA 84th Scientific Sessions (2024): mean weight loss of 10.3%, 11.2%, and 15.6% at 1.2 mg, 1.8 mg, and 2.4 mg respectively versus 2.2% with placebo at week 48. Significant reductions in liver fat (up to 78.6% at high dose) and favourable lipid profile improvements observed. Altimmune completed end-of-Phase 2 meeting with FDA in 2026, advancing towards Phase 3 in obesity.

RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

RECLAIM is a randomised, double-blind, placebo-controlled Phase 2 trial evaluating once-weekly subcutaneous pemvidutide 2.4 mg versus placebo for 24 weeks in approximately 100 adults with alcohol use disorder (AUD) and comorbid obesity or overweight. Enrollment was completed ahead of schedule in November 2025. The primary endpoint is change from baseline in average number of heavy drinking days (TLFB method) over the final 4 weeks. Topline results anticipated Q3 2026. The FDA has granted Fast Track Designation to pemvidutide for AUD. The trial builds on emerging evidence that GLP-1 receptor activation reduces alcohol craving via reward pathway modulation.

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

RESTORE is a Phase 2, randomised, double-blind, placebo-controlled trial evaluating pemvidutide in adults with alcohol-associated liver disease (ALD). The study targets the dual hepatic and metabolic mechanism of pemvidutide — its glucagon receptor agonism directly reduces liver fat, inflammation and fibrosis, while GLP-1 receptor activation provides appetite suppression and weight loss. ALD is a distinct indication from MASH with active alcohol exposure as the primary driver. Trial was initiated in late 2025. FDA has granted Fast Track Designation for pemvidutide in ALD.