Pemvidutide: what the studies show

ALT-801 has two meanings

Pemvidutide is Altimmune's investigational glucagon and GLP-1 receptor agonist, previously called ALT-801. The same code also appears in unrelated oncology research for an IL-2 fusion protein. Check the sponsor and molecule when searching for ALT-801.

Pemvidutide has no FDA-approved product. Altimmune reports phase 3 MASH development through PERFORMA. Fast Track and Breakthrough Therapy designations do not authorize routine prescribing.

MASH resolution and fibrosis

The phase 2b IMPACT trial randomized 212 adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis, or MASH, and F2 or F3 fibrosis. Participants received weekly subcutaneous treatment or placebo.

At 24 weeks, MASH resolution without worsening fibrosis occurred in 58% and 52% of pemvidutide groups versus 20% with placebo. The other primary endpoint, fibrosis improvement without worsening MASH, did not reach statistical significance. MASH resolution and fibrosis improvement are distinct outcomes.

The 48-week biomarker results

Altimmune reported improved non-invasive fibrosis measures at 48 weeks in the same study. Those measurements do not replace the 24-week biopsy finding or constitute another trial. Whether pemvidutide prevents liver failure, cirrhosis complications, or death still requires clinical outcome evidence. The study schedule does not establish a validated self-use regimen.