What is it?
Pemvidutide is an investigational, long-acting peptide designed to influence two hormone signals involved in appetite, blood sugar, and liver metabolism.
Gathering the record
Relay is organizing the evidence and source boundaries.
Long-acting balanced glucagon / GLP-1 dual receptor agonist peptide
Pemvidutide is a long-acting balanced glucagon/GLP-1 dual agonist peptide studied for obesity and liver disease. Controlled trials show weight, liver-fat, and MASH-resolution signals, but fibrosis improvement and Phase 3 confirmation remain incomplete.
60-Second Overview
Start with what it is, why it matters, what research has shown, and what remains unknown. The science follows after the orientation.
Start here. These four answers explain why the compound matters before the page introduces the deeper science.
Pemvidutide is an investigational, long-acting peptide designed to influence two hormone signals involved in appetite, blood sugar, and liver metabolism.
Researchers are testing whether combined gut-hormone and energy-regulation signals can address both weight and metabolic liver disease. The liver program uses imaging and tissue samples to ask different questions about fat, inflammation, and scarring.
Randomized trials have reported reduced liver fat, average weight reduction, and more resolution of metabolic dysfunction-associated steatohepatitis, or MASH, without worsening fibrosis. In the biopsy study, however, the separate fibrosis-improvement goal was not met, so the positive and negative findings must remain together.
Reproducible fibrosis improvement, clinical liver outcomes, Phase 3 confirmation, cardiovascular safety, durability, and uses outside the studied populations remain unresolved. Pemvidutide is not approved.
The research depth, routes, studies, and primary sources below explain how Relay knows—and where the evidence stops.
Research context
Published research has investigated this compound using the following study designs.
These records explain what researchers did. They are not instructions, recommendations, or a transferable protocol.
A published biopsy-based trial evaluated pemvidutide in adults with MASH and moderate or advanced liver fibrosis.
Reported study administration—not a recommendation.
Research at a glance
Evidence depth, confidence, and route context explain how Relay knows—not what anyone should do.
Randomized Phase 2 obesity and liver studies include MRI and biopsy endpoints.
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Weight, liver-fat, and MASH-resolution signals are controlled; fibrosis and clinical outcomes remain unconfirmed.
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
The strongest evidence type shows what the best-supported conclusions are actually based on.
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
These are exposures used in cited research for a specific route and population—not an instruction for an individual.
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: MASH resolution improved, but the separate fibrosis-improvement endpoint was not statistically significant. Imaging and short follow-up cannot establish fewer clinical liver events, approval, or independent-product equivalence. Amounts shown describe cited research exposure—not a dosage recommendation.
Detailed evidence
Start with the strongest supported conclusion and its main uncertainty. Claim-level records below show how the evidence changes by question, population, route, formulation, and study design.
Randomized Phase 2 and Phase 2b studies with liver MRI, biopsy, body-weight, metabolic, and safety endpoints, including a published 212-participant MASH trial.
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
Whether MASH resolution translates into reproducible fibrosis improvement and clinical liver outcomes, plus long-term cardiovascular safety, durability, and Phase 3 benefit-risk.
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
Questions people bring to the evidence
Research questions—not promises of benefit.
Its EuPort conjugation is intended to prolong exposure while retaining both receptor activities.
This is direct biopsy-based human evidence for liver disease activity.
The negative co-primary result prevents describing the trial as a confirmed antifibrotic success.
MRI-PDFF, liver enzymes, body weight, and lipid markers moved in favorable directions.
The weight signal is human and randomized, though the candidate is no longer positioned only as an obesity drug.
Active trials do not yet demonstrate reduced drinking or improved liver outcomes.
Clinical-trial product handling cannot validate research-market vials.
Mechanisms
Pemvidutide (ALT-801) is a balanced 1:1 glucagon/GLP-1 receptor dual agonist conjugated to a lipid-like EuPort domain for prolonged exposure. Controlled MASLD research demonstrated large reductions in liver fat, body weight, and markers of hepatic inflammation. In the 212-participant IMPACT Phase 2b biopsy trial, pemvidutide met the primary endpoint of MASH resolution without worsening fibrosis at 24 weeks, but did not significantly meet the co-primary fibrosis-improvement endpoint. Forty-eight-week noninvasive markers reported by the sponsor supported continued antifibrotic investigation. The MOMENTUM obesity program showed substantial weight reduction but was Phase 2. Phase 3 MASH development is planned, while alcohol-use and alcohol-associated-liver-disease studies are ongoing. No regulatory approval or completed clinical-outcomes evidence exists.
A plausible mechanism can explain why a study was attempted. It does not prove that the compound improves a human outcome.
Studies
Study arms are reported for transparency. They describe what researchers did in a defined record and do not transfer across identities, routes, formulations, or populations.
A later trial phase can ask a more mature question, but it does not guarantee a positive result, regulatory approval, or relevance outside the studied population.
Randomized, double-blind, placebo-controlled biopsy trial
Adults with biopsy-confirmed MASH and F2/F3 fibrosis, with or without diabetes
Pemvidutide met the MASH-resolution primary endpoint but did not significantly improve the co-primary fibrosis endpoint at 24 weeks.
Study administration: Once-weekly pemvidutide 1.2 mg, 1.8 mg, or placebo
Limitations: The positive and negative co-primary findings must be presented together; noninvasive 48-week markers cannot substitute for a confirmatory biopsy or clinical outcomes.
Randomized, placebo-controlled MASLD trial
Adults with metabolic dysfunction-associated steatotic liver disease
Pemvidutide produced large dose-related liver-fat reductions along with weight and metabolic-marker improvements.
Study administration: Multiple once-weekly pemvidutide doses or placebo
Limitations: MRI liver fat and enzymes are surrogate measures and do not establish fibrosis regression or fewer clinical liver events.
Diet-induced obesity and liver-disease animal models
Rodent metabolic models
ALT-801 reduced body weight and liver-related metabolic measures in preclinical models.
Study administration: ALT-801 versus control conditions
Limitations: Animal metabolic effects do not establish human clinical outcomes or safety.
Randomized, double-blind, placebo-controlled obesity trial
Adults with obesity or overweight
MOMENTUM demonstrated substantial mean weight reduction and improvements in selected cardiometabolic markers.
Study administration: Once-weekly pemvidutide dose groups or placebo
Limitations: The full peer-reviewed obesity report was not identified in the same depth as the liver publications; sponsor-reported estimates require that boundary.
Randomized trial in alcohol use disorder
Adults with alcohol use disorder and obesity or overweight
RECLAIM is testing a new indication beyond MASH and obesity.
Study administration: Pemvidutide or placebo
Limitations: No completed efficacy results were available at the cutoff.
Safety snapshot
No source-qualified adverse-event pattern is represented in the current record.
Evidence boundaryHuman exposure is present, but the record is not detailed enough to characterize a reliable adverse-event pattern.
The current record does not support a reliable common-versus-uncommon frequency split.
Evidence boundaryUnder-detected or under-reported events must not be described as rare.
No source-qualified compound-specific warning or contraindication is encoded in the current record.
Evidence boundaryInvestigational; Phase 3 MASH planning and active liver-disease research Whether MASH resolution translates into reproducible fibrosis improvement and clinical liver outcomes, plus long-term cardiovascular safety, durability, and Phase 3 benefit-risk.
The current record does not identify a reliable compound-specific pattern of events that caused study discontinuation.
Evidence boundaryThis is an evidence gap, not proof that discontinuations did not occur.
No compound-specific patient-facing urgent-action threshold is established in the current Relay record.
Evidence boundaryRelay does not infer emergency guidance from study discontinuations, mechanism, or incomplete adverse-event reporting.
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