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Home/Compounds/Efpeglenatide
GLP-1 agonistRx required

Efpeglenatide

Also known as: HM11260C

Investigational long-acting GLP-1 receptor agonist under development by Hanmi Pharmaceutical.

B
Grade B
Human observational studies
Human studies26
PubMed citations30
Routesubcutaneous
Regulatory (US)Rx required
Last verified2 days ago

Mechanism of action

Exendin-4 analog conjugated to an immunoglobulin Fc fragment via proprietary LAPS technology. Half-life supports once-weekly to monthly dosing.

Evidence summary

26
Human studies
30
PubMed citations
5
Clinical trials
B
Evidence grade

AMPLITUDE clinical program. AMPLITUDE-O cardiovascular outcomes trial published 2021.

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 — clinical trials ongoing

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT03353350A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and ExerciseCompleted · Phase 3 · Type 2 Diabetes Mellitus · n=406NCT03770728A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With SulfonylureaTerminated · Phase 3 · Type 2 Diabetes Mellitus · n=312NCT03713684A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)Terminated · Phase 3 · Type 2 Diabetes Mellitus · n=370NCT03684642A 56-week, Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly Compared to Dulaglutide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With MetforminTerminated · Phase 3 · Type 2 Diabetes Mellitus · n=908NCT03496298A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular RiskTerminated · Phase 3 · Type 2 Diabetes Mellitus · n=4076

Citations

PMID 41967797Abomohsen M, Rifai M et al. · Preferred GLP-1 Receptor Agonists in Type 2 Diabetes With Established Cardiovascular Disease or High Cardiovascular Risk: A Network Meta-Analysis of Randomized Trials.Canadian journal of diabetes (2026)PMID 39910752An X, Sun W et al. · Comparison of the efficacy and safety of GLP-1 receptor agonists on cardiovascular events and risk factors: A review and network meta-analysis.Diabetes, obesity & metabolism (2025)HumanPMID 41403449Choi S, Seo J et al. · Population pharmacokinetics of efpeglenatide in individuals with obesity and with type 2 diabetes.Frontiers in pharmacology (2025)PMID 39917155Narayan N, Vadde T et al. · Efficacy and Safety of Efpeglenatide in Patients With Type 2 Diabetes and Obesity: A Systematic Review.Cureus (2025)PMID 40943127Hsu CW, Zeng BS et al. · The Preventive Effects of GLP-1 Receptor Agonists and SGLT2 Inhibitors on Cancer Metastasis: A Network Meta-Analysis of 67 Randomized Controlled Trials.International journal of molecular sciences (2025)HumanPMID 40892610Galli M, Benenati S et al. · Cardiovascular Effects and Tolerability of GLP-1 Receptor Agonists: A Systematic Review and Meta-Analysis of 99,599 Patients.Journal of the American College of Cardiology (2025)HumanPMID 40016997Alkhouri N, Charlton M et al. · The pleiotropic effects of glucagon-like peptide-1 receptor agonists in patients with metabolic dysfunction-associated steatohepatitis: a review for gastroenterologists.Expert opinion on investigational drugs (2025)HumanPMID 40430553Chen JJ, Hsu CW et al. · Risk of Hearing Loss in Patients Treated with Exendin-4 Derivatives: A Network Meta-Analysis of Glucagon-like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors.Pharmaceuticals (Basel, Switzerland) (2025)HumanPMID 40265328Ali A, Siddiqui AA et al. · Effect of glucagon-like peptide 1 receptor agonists on systolic blood pressure in patients with obesity, with or without diabetes: A systematic review and network meta-analysis.Clinical obesity (2025)HumanPMID 35126141Dahlén AD, Dashi G et al. · Trends in Antidiabetic Drug Discovery: FDA Approved Drugs, New Drugs in Clinical Trials and Global Sales.Frontiers in pharmacology (2024)HumanPMID 37885518Escobar J, Monday O et al. · Safety and Efficacy of Efpeglenatide in Patients With Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials.Cureus (2023)PMID 37491292Yu M, Wang R et al. · The relationship between the use of GLP-1 receptor agonists and the incidence of respiratory illness: a meta-analysis of randomized controlled trials.Diabetology & metabolic syndrome (2023)HumanPMID 36802715Gerstein HC, Li Z et al. · Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial.Circulation (2023)HumanPMID 37532422Neves JS, Borges-Canha M et al. · GLP-1 Receptor Agonist Therapy With and Without SGLT2 Inhibitors in Patients With Type 2 Diabetes.Journal of the American College of Cardiology (2023)HumanPMID 35925683Madsbad S, Holst JJ · Cardiovascular effects of incretins: focus on glucagon-like peptide-1 receptor agonists.Cardiovascular research (2023)HumanPMID 37013892Aroda VR, Frias JP et al. · Efficacy and safety of once-weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE-D, AMPLITUDE-L and AMPLITUDE-S randomized controlled trials.Diabetes, obesity & metabolism (2023)HumanPMID 37231200García-Casares N, González-González G et al. · Effects of GLP-1 receptor agonists on neurological complications of diabetes.Reviews in endocrine & metabolic disorders (2023)HumanPMID 36203939Kreiner FF, Hovingh GKK et al. · The potential of glucagon-like peptide-1 receptor agonists in heart failure.Frontiers in physiology (2022)HumanPMID 35042751Pratley RE, Jacob S et al. · Efficacy and safety of efpeglenatide in key patient subgroups from the BALANCE randomized trial, stratified by pre-diabetes status, BMI, and age at baseline.BMJ open diabetes research & care (2022)HumanPMID 34526024Giugliano D, Scappaticcio L et al. · GLP-1 receptor agonists and cardiorenal outcomes in type 2 diabetes: an updated meta-analysis of eight CVOTs.Cardiovascular diabetology (2022)Human

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