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Home/Compounds/Pemvidutide
GLP-1 agonistRx required

Pemvidutide

Also known as: ALT-801

Investigational dual GLP-1 / glucagon receptor agonist in Phase 2 trials for obesity and MASH.

B
Grade B
Human observational studies
Human studies12
PubMed citations14
Routesubcutaneous
Regulatory (US)Rx required
Last verified2 days ago

Mechanism of action

Balanced dual agonist at GLP-1 and glucagon receptors.

Evidence summary

12
Human studies
14
PubMed citations
7
Clinical trials
B
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
subcutaneous

Side effects & safety

No FDA label or editorial side-effect profile is on file for this compound yet. See the clinical trials and citations sections for study-reported safety data.

Interactions

No documented drug interactions on file.

Regulatory status

United States
Not FDA approved

Investigational — Phase 2 clinical trials

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT07009860RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)Recruiting · Phase 2 · Alcohol Liver Disease · n=100NCT05989711A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)Completed · Phase 2 · Non-Alcoholic Steatohepatitis (NASH) · n=212NCT06987513RECLAIM STUDY: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or OverweightActive Not Recruiting · Phase 2 · Alcohol Use Disorder (AUD) · n=100NCT04972396An Open-label Study of the Effect of ALT-801 on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin, Digoxin, and the Combined Oral Contraceptive Ethinylestradiol/Levonorgestrel in Healthy VolunteersCompleted · Phase 1 · NASH - Nonalcoholic Steatohepatitis · n=40NCT04561245A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese VolunteersCompleted · Phase 1 · Obesity · n=100NCT05292911A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)Completed · Phase 1 · Non-Alcoholic Fatty Liver Disease · n=64NCT05006885A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver DiseaseCompleted · Phase 1 · Non-Alcoholic Fatty Liver Disease · n=95

Citations

PMID 41661442Nordell P, Jansson-Löfmark R et al. · Systemic Pharmacokinetic Principles of Therapeutic Peptides.Clinical pharmacokinetics (2026)HumanPMID 41696398Patil S, Jha N et al. · Glucagon-like peptide 1 receptor agonists in substance use disorders: A systematic review of ClinicalTrials.Gov.Addictive behaviors reports (2026)HumanPMID 41879841Rajab I, Emara A et al. · Efficacy and safety of pemvidutide in metabolic dysfunction-associated steatohepatitis: a GRADE-assessed meta-analysis of randomized controlled trials.Naunyn-Schmiedeberg's archives of pharmacology (2026)PMID 40081498Bailey CJ, Flatt PR et al. · Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities.Peptides (2025)HumanPMID 41362110von Haehling S, Sato R et al. · Muscle Loss in Obesity Therapy as a Therapeutic Target: Trial Design and Endpoints for Regulatory Discussions.Journal of cachexia, sarcopenia and muscle (2025)HumanPMID 40063921Pinsky LL, Khaitovych MV et al. · Current priorities in research on metabolic-associated fatty liver disease based on the results of EASL - 2024.Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego (2025)HumanPMID 41113119Browne SK, Suschak JJ et al. · Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial.JHEP reports : innovation in hepatology (2025)PMID 41237796Noureddin M, Harrison SA et al. · Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study.Lancet (London, England) (2025)HumanPMID 40734920Anderson SL · Review: Special Issue: Real-world evidence on the use of GLP1 receptor agonists: Emerging concepts in obesity management: focus on glucagon receptor agonist combinations.Drugs in context (2025)HumanPMID 39676791Sidrak WR, Kalra S et al. · Approved and Emerging Hormone-Based Anti-Obesity Medications: A Review Article.Indian journal of endocrinology and metabolism (2025)HumanPMID 39002641Harrison SA, Browne SK et al. · Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study.Journal of hepatology (2024)HumanPMID 35461369Nestor JJ, Parkes D et al. · Effects of ALT-801, a GLP-1 and glucagon receptor dual agonist, in a translational mouse model of non-alcoholic steatohepatitis.Scientific reports (2022)HumanPMID 21994418Fishman MN, Thompson JA et al. · Phase I trial of ALT-801, an interleukin-2/T-cell receptor fusion protein targeting p53 (aa264-272)/HLA-A*0201 complex, in patients with advanced malignancies.Clinical cancer research : an official journal of the American Association for Cancer Research (2012)HumanPMID 20383346Tomillero A, Moral MA · Gateways to clinical trials.Methods and findings in experimental and clinical pharmacology (2010)Human