Pemvidutide
InvestigationalInvestigational GLP-1/glucagon dual agonist. The published IMPACT Phase 2b trial met its 24-week MASH-resolution endpoint but not its fibrosis-improvement co-primary endpoint. Phase 3 PERFORMA in MASH has begun. Altimmune also reported positive Phase 2 RECLAIM alcohol-use-disorder toplines in July 2026; these sponsor results are not yet a peer-reviewed paper or FDA approval.
ALT-801 · GLP-1/Glucagon Dual Agonist
Published IMPACT findings retain both MASH-resolution and fibrosis endpoints; MOMENTUM and RECLAIM sponsor claims remain separate from published efficacy.
- Preclinical
- 0%
- Human research
- 25%
Based on 12 cited sources
12 deduplicated reader-visible evidence records: 3 direct primary human publications, 0 direct primary preclinical publications and 1 verified scholarly open full texts. Registrations, sponsor or regulator records, reviews and protocols have different evidentiary roles from direct primary papers; a publication and registration may describe the same trial, and post-hoc or substudy reports may reuse a population.
Pemvidutide activates GLP-1 and glucagon receptors. Clinical trials measure weight and liver outcomes but do not isolate how much each receptor pathway contributes in people.
How It Works (Simplified)
Pemvidutide activates two hormone receptors:
GLP-1 receptor activation in the brain signals satiety, reducing hunger and caloric intake naturally.
Glucagon-receptor signalling may affect hepatic lipid metabolism. Liver-fat and MASH outcomes were measured, but their specific causal pathway was not isolated.
A contribution from energy expenditure is biologically plausible; its magnitude in people receiving pemvidutide was not established by the cited efficacy trials.
Body-composition analyses in MOMENTUM are exploratory; no head-to-head trial established greater fat-mass selectivity than a GLP-1-only medicine.
Key Research: The published IMPACT phase 2b trial reported more MASH resolution without worsening of fibrosis at 24 weeks, but did not meet its separate conventional-histology fibrosis co-primary endpoint (PMID:41237796). MOMENTUM obesity results are sponsor-reported and identified by its trial registration; the registration is not a peer-reviewed results paper.
MASH and alcohol use disorder updates
In the published IMPACT Phase 2b trial of 212 adults with biopsy-confirmed MASH and F2–F3 fibrosis, MASH resolution without worsening of fibrosis at 24 weeks was more frequent with pemvidutide than placebo. The separate co-primary endpoint of fibrosis improvement without worsening of MASH was not statistically significant in the conventional histology analysis (PMID:41237796). Altimmune’s 48-week update described changes in non-invasive fibrosis markers and further weight reduction, but these are sponsor toplines and do not turn the missed 24-week biopsy endpoint into a positive one. Altimmune says the PERFORMA Phase 3 MASH trial began in July 2026 (August 2026 corporate update); trial registration is a study plan, not an efficacy result.
In RECLAIM (NCT06987513), a separate Phase 2 trial in about 100 adults with moderate-to-severe alcohol use disorder, Altimmune reported on 28 July 2026 a week-24 mean reduction of 4.20 heavy drinking days per week from baseline with pemvidutide versus 2.75 with placebo (difference 1.45 days, p=0.0014). The company also reported a two-level WHO risk-drinking reduction in 64.4% versus 34.8% and zero heavy drinking days during weeks 21–24 in 42.2% versus 17.4%. These are sponsor-reported toplines, with no peer-reviewed RECLAIM paper or posted registry results table verified here. FDA Fast Track for AUD and Breakthrough Therapy for MASH are development designations, not approval or an agency determination of efficacy.
Important Limitations
- Phase 3 PERFORMA (NCT07795164) has begun, but there is no Phase 3 efficacy result
- RECLAIM AUD results are sponsor toplines pending detailed peer review and registry posting
- A missing ClinicalTrials.gov results table does not negate the sponsor’s RECLAIM topline, but limits independent detail
- RESTORE ALD (NCT07009860) active, not recruiting — no results
- No head-to-head comparisons with approved agents
- Long-term safety and durability beyond the published Phase 2 window unknown
- Registrational and Phase 2 programs remain Altimmune-sponsored
| NCT ID | Title | Peptide | Phase | Status | Completion |
|---|---|---|---|---|---|
| NCT07795164 | Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH Metabolic Dysfunction-Associated Steatohepatitis (MASH) | Pemvidutide | Phase 3 | Recruiting | Dec 2032 (estimated) |
| NCT07009860 | RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) Alcohol-associated Liver Disease | Pemvidutide | Phase 2 | Active not recruiting | Sep 2027 (estimated) |
| NCT06987513 | RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight Alcohol Use Disorder (AUD) | Pemvidutide | Phase 2 | Completed | Jul 2026 |
| NCT05989711 | IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) Non-Alcoholic Steatohepatitis (NASH) | Pemvidutide | Phase 2 | Completed | Nov 2025 |
Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
Published group averages showed relative liver-fat reduction of 46.6% to 68.5% across pemvidutide arms versus 4.4% with placebo. This is a different population from the MOMENTUM obesity trial.
PMID:39002641Biopsy-confirmed MASH resolution without worsening fibrosis met its primary endpoint, while the co-primary fibrosis-improvement endpoint did not. These are trial-level outcomes, not an individual timeline.
PMID:41237796Research-based observations
This timeline reflects observations from published clinical and preclinical studies. Individual responses may vary significantly. This is not a guarantee of effects or a dosing schedule. Consult qualified healthcare providers for personalized guidance.
Semaglutide
CautionBoth target GLP-1 receptors. Co-administration would result in overlapping mechanisms with potential for increased GI side effects. Not recommended to combine.
BPC-157
CautionNo clinical co-administration study was identified; compatibility and any protective effect are unestablished.
TB-500
CautionNo clinical co-administration study was identified, so interaction and safety are unknown.
Tirzepatide
AvoidBoth agents activate GLP-1 receptors. No pemvidutide/tirzepatide combination trial was identified, so clinical effects and safety are unknown; receptor overstimulation is a theoretical concern.
Survodutide
AvoidBoth are investigational GLP-1/glucagon dual agonists. Their concurrent use has not been studied, so the risk magnitude is unknown.
Research Note: Interaction data is based on published literature, mechanistic understanding, and theoretical considerations. Most peptide combinations lack direct clinical study. This information is for educational purposes only and does not constitute medical advice. Always consult qualified healthcare providers.
Key Studies Cited
Use the source links in the research discussion above to inspect the referenced records.
This dossier synthesizes available evidence from peer-reviewed literature, regulatory documents, and clinical trial registries. Evidence strength labels summarize the cited material for this entry and should be read alongside its population, model, and study limitations.
For complete methodology details, see our Methodology page.
Important Disclaimer
This dossier is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.
Get Research Alerts
New dossiers and major study summaries delivered to your inbox. Evidence-graded, citation-backed research you can trust.
No spam. Unsubscribe anytime.
Compare Pemvidutide
Related Peptides
5-Amino-1MQ
5-Amino-1-Methylquinolinium · NNMT Inhibitor
A small molecule NNMT inhibitor studied for metabolic effects in animal models. No human clinical trials have been conducted. Increases NAD+ levels in adipose tissue in preclinical studies.
Amycretin
NNC0487-0111 · Oral Amycretin · Subcutaneous Amycretin
A novel single-molecule dual GLP-1/amylin receptor agonist developed by Novo Nordisk. Unlike CagriSema (a fixed-dose combination), amycretin is a unified peptide that activates both pathways. Phase 1 trials showed superior weight loss signals versus semaglutide, with both oral and subcutaneous formulations in development.
AOD-9604
Anti-Obesity Drug 9604 · Tyr-hGH Fragment 177-191
AOD-9604 is a modified human-growth-hormone fragment investigated for obesity and fat metabolism. Its obesity development program did not establish efficacy, and current regulatory sources identify major safety and quality gaps for unapproved or compounded products.
Cagrilintide
AM833 · NN9838
Investigational long-acting amylin analogue. REDEFINE 1 included a Phase 3 cagrilintide-only arm; Novo reports 11.8% mean weight loss versus 2.3% with placebo at 68 weeks using an on-treatment estimand. Dedicated RENEW Phase 3 monotherapy trials have started. Cagrilintide is also a CagriSema component.
CagriSema
Cagrilintide-Semaglutide · NNC0174-0833
Investigational fixed-dose cagrilintide plus semaglutide combination. Novo filed a US obesity NDA in December 2025. Its sponsor-reported REDEFINE 4 head-to-head trial missed non-inferiority versus tirzepatide; September 2026 REIMAGINE 5 and REDEFINE 9 toplines address different populations and doses. A filing and positive toplines are not FDA approval.
CT-388
RG-6912
A dual GLP-1/GIP receptor agonist (INN enicepatide; also RO7795068) acquired by Roche through the $2.7 billion Carmot Therapeutics acquisition in 2024. The published Phase 1 trial (NCT04838405) showed 4.7-8.0% mean weight loss vs 0.5% placebo over 4 weeks; a more widely reported ~18.8% placebo-adjusted figure at 24 weeks comes from an unpublished Phase 1 extension reported via press release. Phase 2 obesity and T2D trials are completed or ongoing and Phase 3 began in 2026, positioning it as a competitive obesity therapeutic with a mechanism similar to tirzepatide.
Compared With
11 comparisonsConditions Studied
3 entries- Pemvidutide for Obesity Altimmune reported 15.6% mean weight reduction at 48 weeks in one MOMENTUM phase 2b obesity arm. That sponsor result is not a cite…
- Pemvidutide for MASH (Metabolic Dysfunction-Associated Steatohepatitis) Phase 2 IMPACT trial (NCT05989711) met its MASH-resolution primary endpoint at 24 weeks: 52% MASH resolution without fibrosis wors…
- Pemvidutide for Metabolic Syndrome The cited obesity and MASH registrations do not establish a metabolic-syndrome treatment effect. Cardiometabolic markers have been…