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In clinical trialsEarly human evidence

Plain-English fact sheet

Pemvidutide

Also known as ALT-801

Weight managementMetabolic health

Pemvidutide is a dual metabolic peptide with encouraging Phase 2 liver and weight signals, but no FDA-approved use and no completed confirmatory program.

Quick answer

Pemvidutide is not FDA approved. Phase 2 studies report reductions in liver fat, MASH activity, and body weight, but confirmatory evidence, fibrosis benefit, long-term safety, and major clinical outcomes remain unresolved.

By the PeptideFactSheets Editorial Team. Claims are source-checked under our editorial policy; clinician review is identified only when a named reviewer is shown.

What is Pemvidutide?

Pemvidutide is a manufactured peptide designed to activate GLP-1 and glucagon receptors.

It is being developed primarily for metabolic liver disease and obesity, with trial endpoints spanning imaging, biopsy, biomarkers, and weight.

Why are people interested in it?

Its glucagon activity is intended to add liver-fat and energy-expenditure effects to GLP-1 biology.

Positive mid-stage results are scientifically meaningful but remain less mature than a successful confirmatory program or regulatory approval.

Current regulatory status

In clinical trials

Pemvidutide remains investigational in the United States. Its MASH and obesity programs have not produced an FDA-approved product.

What is it approved for?

No FDA-approved use. This matters because clinical-trial participation and products marketed online are not the same as an approved medicine.

What is it being studied for?

MASH and MASLD
Liver fat
Obesity
Fibrosis and cardiometabolic markers

Investigational areas

  • MASH with fibrosis
  • Chronic weight management
  • Metabolic liver disease

Evidence snapshot

Early human evidence

Randomized Phase 2 studies support biological and clinical signals, including liver-fat and biopsy outcomes. Larger confirmatory trials and longer safety follow-up are still needed.

Potential benefits being researched

  • A randomized MASLD study reported lower liver fat and body weight than placebo.
  • The IMPACT Phase 2b study reported MASH-resolution signals, while a clear confirmatory fibrosis benefit remains a central question.

Potential does not mean proven. Study design, population, endpoint, and regulatory review matter.

Known or possible risks

  • Gastrointestinal adverse effects are common across this drug class and appeared in pemvidutide trials.
  • Trial discontinuations and sponsor-selected analyses can affect apparent efficacy.
  • Uncommon and long-term harms are not yet characterized as they are for approved medicines.

What we still do not know

  • Whether MASH improvements are confirmed in Phase 3
  • Whether fibrosis and liver-related clinical outcomes improve
  • Long-term cardiovascular and safety outcomes
  • How its benefit-risk profile compares directly with other incretin and glucagon co-agonists

Plain-English takeaway

Pemvidutide has credible mid-stage liver and weight data, but it is still a Phase 2 research program rather than an established MASH or obesity medicine.

Research and reference links

Use these primary and reputable sources to verify status and read beyond this summary. Trial registries may list studies without proving a benefit.

  1. 1
    Randomized pemvidutide MASLD study

    Controlled trial of liver-fat, inflammatory, and body-weight outcomes.

  2. 2
    IMPACT Phase 2b MASH trial

    Biopsy-based MASH and fibrosis study with short primary follow-up.

  3. 3
    ClinicalTrials.gov: IMPACT

    Official Phase 2b trial design, status, population, and endpoints.