Pemvidutide has controlled human studies in obesity and serious fatty-liver disease (MASH). A global Phase 3 MASH programme is now active, but pemvidutide remains investigational and is not an approved medicine.
Still uncertain: Marketing approval, long-term liver outcomes, definitive fibrosis benefit, cardiovascular outcomes and routine-use dosing.
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What does the evidence mean in simple terms? table
Randomized Phase 2 obesity and MASH studies show weight-loss, liver-fat and MASH-resolution signals. The global PERFORMA Phase 3 MASH programme is active; pemvidutide remains investigational.
Regulatory status
Investigational. FDA granted Breakthrough Therapy Designation for MASH based on early clinical evidence; this is not marketing approval.
Main limitations
Marketing approval, long-term liver outcomes, definitive fibrosis benefit, cardiovascular outcomes and routine-use dosing are not established.
Safety
GI tolerability and liver-disease population safety are being characterised; longer-term and rare-event data remain limited.
Evidence reviewed
2026-09-18
i
Randomized Phase 2 obesity and MASH studies show weight-loss, liver-fat and MASH-resolution signals. The global PERFORMA Phase 3 MASH programme is active; pemvidutide remains investigational.
Outcome-level evidence
Evidence is not one score.
Each record below answers a narrower question about an outcome, population or context. Evidence status and the study finding are shown separately so strong evidence is not mistaken for a positive effect.
GI tolerability and liver-disease population safety are being characterised; longer-term and rare-event data remain limited.
Adverse events are common but mostly mild-to-moderate in reported trials; gastrointestinal tolerability remains important. Fibrosis benefit was not statistically significant at 24 weeks in the Phase 2b IMPACT primary fibrosis endpoint.
Technical details
Mechanism / biologyBalanced GLP-1/glucagon receptor agonism aims to reduce appetite and body weight while increasing hepatic fat oxidation and improving metabolic liver disease.
Route / formulation boundaryTrial-grade once-weekly subcutaneous product; Breakthrough Therapy designation must not be presented as FDA approval.
Identity / data-quality noteSeparate obesity, MASLD and biopsy-confirmed MASH endpoints; do not treat Breakthrough Therapy as approval.
Study / label regimen evidenceMultiple Phase 2 human regimens verified. MOMENTUM studied 1.2, 1.8 and 2.4 mg weekly for 48 weeks; IMPACT studied 1.2 and 1.8 mg weekly without titration.
WhichPeps does not rely on a single headline study when the evidence base is broader. Primary research, registries, regulators and supporting records are kept distinct.
2structured study records
2outcome records
5linked source records
How to read these counts: they show evidence coverage, not evidence strength. One large, well-designed study can be more informative than several weak or indirect records.
Show supporting and discovery sources
Study pages above contain the records used for public evidence summaries. The links below include supporting, regulatory and literature-discovery sources; a registry or search result is not treated as proof of benefit.
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
