Evidence memo / Metabolic & weight

Pemvidutide

Also: ALT-801 · GLP-1/glucagon receptor agonist

Pemvidutide is an investigational dual GLP-1 and glucagon receptor agonist being developed for obesity and for metabolic liver disease (MASH). It is not approved. Phase 2 trials have reported weight and liver-fat effects. The Watchlist boundary is keeping it to its investigational obesity and liver program and not generalizing early results.

Controlled human dataPhase 2 / Phase 3InvestigationalSafety / regulatory watch

The verdict

Our read at a glance.

Whether pemvidutide's dual GLP-1 and glucagon approach delivers durable obesity and liver-disease benefits in larger trials and leads to approval.

The signal
Phase 2 trials have reported weight loss in obesity and effects on metabolic liver disease (MASH) markers. As an investigational drug, its full efficacy and safety remain to be established.
The unknown
Whether its weight and liver benefits hold up against tolerability in larger trials, and how it compares with GLP-1, dual, and triple agonists.
Our read
An investigational dual agonist for obesity and liver disease, not yet proven or approved. Pemvidutide's Phase 2 data are early, and until larger results and any approval it should be read as investigational.

The mechanism

How it works.

Pemvidutide is an injectable peptide that activates both the GLP-1 receptor and the glucagon receptor. The GLP-1 arm signals the brain to curb appetite and helps regulate blood sugar, while the glucagon arm raises energy expenditure and drives the liver to break down stored fat. Targeting liver fat through glucagon alongside weight loss is the basis for developing it in both obesity and fatty liver disease (MASH), and as an investigational drug those effects are still being tested rather than proven.

Safety & regulatory boundary

The consequential part.

Pemvidutide is investigational and not an approved product. Its safety profile, including gastrointestinal effects and the heart-rate and other effects associated with glucagon-containing agonists, is still being characterized. Research-labeled or compounded pemvidutide is not an approved product, and its development status does not support use outside trials.

What's next

What we're watching.

Phase 2 and Phase 3 obesity and MASH results, regulatory progress, and comparisons with other incretin and dual or triple agonists.

Context

Why this is discussed.

Pemvidutide is one of the GLP-1/glucagon dual agonists in development, of interest because the glucagon component may help with liver fat in addition to weight.

The evidence base

13 cited references.

Keep reading

Related published memos.