Pemvidutide

Pemvidutide (ALT-801)

Evidence & Status

  • Strong

Overview

Pemvidutide (ALT-801) is an investigational once-weekly dual agonist of the GLP-1 and glucagon receptors studied in metabolic and liver disease. Randomized human trials evaluated liver fat, body weight and metabolic dysfunction-associated steatohepatitis (MASH). It is not FDA-approved.

Research Summary

Randomized human trials reported reductions in liver fat and body weight. In the 24-week IMPACT Phase 2b trial, MASH resolution without worsening fibrosis occurred in 58% of participants receiving 1.2 mg and 52% receiving 1.8 mg, compared with 20% receiving placebo. The separate endpoint of at least one-stage fibrosis improvement without worsening MASH was 33% and 36% versus 28% with placebo and was not statistically significant. Adverse events were more frequent than with placebo but mostly mild or moderate, and discontinuations due to adverse events were uncommon in that analysis.

Research Areas

  • Weight management
  • Metabolic disease
  • MASH
  • Liver fat

Safety & Risks

Reported Side Effects

  • Adverse events occurred more frequently than with placebo in the 24-week IMPACT analysis, and most were mild or moderate
United States
Investigational; not FDA-approved
United Kingdom
Current authorization status not established in this record.
Australia
Current authorization status not established in this record.
Canada
Current authorization status not established in this record.

Citations & Sources