efpeglenatide (HM11260C) / Hanmi - LARVOL DELTA

Effect of Efpeglenatide on Heart Failure Outcomes: A Participant-Level Exploratory Analysis of the Randomized AMPLITUDE-O Trial. (PubMed, Diabetes Care) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus (clinicaltrials.gov) - P3 | N=420 | Active, not recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

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. (PubMed, Pharmaceuticals (Basel)) - " This comprehensive NMA identifies a significant association between exendin-4 derivatives (lixisenatide and efpeglenatide) and potential ototoxicity. Clinicians should carefully consider this potential ototoxicity when prescribing exendin-4 derivatives, particularly in patients with pre-existing hearing loss risk factors."

Journal • Retrospective data • Review • Otorhinolaryngology

Cardiovascular safety of GLP-1 Receptor Agonists in Type 2 Diabetes: A Network Meta-Analysis of Cardiovascular Outcomes Trials (ISPOR 2025) - "Efpeglenatide and oral semaglutide gave the largest MACE reduction, with hazard ratios of 0.73 [0.58; 0.92] and 0.74 [0.58; 0.95], respectively. For cardiovascular death, IV semaglutide demonstrated the greatest risk reduction (HR 0.49 [0.27; 0.90]), followed by efpeglenatide and liraglutide... This NMA highlights the significant cardioprotective effects of GLP-1 RAs across multiple cardiovascular outcomes in T2D patients. These findings underscore their potential as valuable therapeutic options for managing cardiovascular risk in this population, warranting further investigation and clinical consideration."

Retrospective data • Cardiovascular • Congestive Heart Failure • Diabetes • Heart Failure • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus

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. (PubMed, Clin Obes) - "MEDLINE and Cochrane were searched until January 2022 for randomized control trials (RCTs) on patients with obesity, evaluating the impact of semaglutide, liraglutide, efpeglenatide, or exenatide on SBP. GLP-1RAs result in mild reductions in SBP in patients with obesity. The change in SBP varies only slightly by the drug-dose combination and appears to be related to the amount of weight loss."

Journal • Retrospective data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Hanmi Pharmaceutical's GLP-1 Triple Agonist 'HM15275' Opens New Horizons in Obesity and Metabolic Disease Treatment [Google translation] (The Korea Economic Daily) - "Currently, HM15275 is scheduled to enter phase 2 clinical trials in the second half of this year. If the clinical development is successful in the future, it is highly likely that it will establish itself as a new game changer in the global obesity treatment market....In addition, 'Efpeglenatide', which was the first HOP project, is currently progressing smoothly in phase 3 clinical trials in Korea. The clinical trial is expected to end in the second half of 2026..."

New P2 trial • Trial completion date • Obesity • Type 2 Diabetes Mellitus

Preoperative Weight Loss Before Total Joint Arthroplasty Using Novel GLP-1 Agonists (AAOS 2025) - "GLP-1s were categorized as Food and Drug Administration (FDA)-approved for weight loss (Group 1: semaglutide and liraglutide) versus FDA-approved for diabetes or under investigation for weight loss (Group 2: dulaglutide, exenatide, lixisenatide, efpeglenatide, tirzepatide plus Group 1 medications). The prevalence of preoperative GLP-1s before TJA tripled to 4.6% from 2019 to 2022, and preoperative weight change on GLP-1s varied considerably. GLP-1s were not associated with increased postoperative risks but investigational GLP-1s before TJA require further study."

Anesthesia • Diabetes • Infectious Disease • Metabolic Disorders • Musculoskeletal Diseases • Orthopedics

The pleiotropic effects of glucagon-like peptide-1 receptor agonists in patients with metabolic dysfunction-associated steatohepatitis: a review for gastroenterologists. (PubMed, Expert Opin Investig Drugs) - "Our narrative review of English articles included four GLP-1RAs (subcutaneous semaglutide, liraglutide, dulaglutide, and efpeglenatide), a dual GLP-1/GIP agonist (tirzepatide), a dual GLP-1/glucagon receptor agonist (survodutide), MASLD/MASH, related disorders, clinical management, treatment outcomes and landscape. Effects on cardiometabolic parameters align with type 2 diabetes/obesity Phase III data, comprising substantial improvements in glycemic, weight, and cardiovascular outcomes. Promising data also suggest benefits in common comorbidities, including obstructive sleep apnea, polycystic ovary syndrome, chronic kidney disease, and heart failure with preserved ejection fraction.GLP-1RAs represent a valuable pharmacotherapeutic option for gastroenterologists managing individuals with MASLD/MASH and cardiometabolic comorbid conditions."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Diabetes • Fibrosis • Gastroenterology • Genetic Disorders • Heart Failure • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Nephrology • Obesity • Obstructive Sleep Apnea • Polycystic Ovary Syndrome • Renal Disease • Respiratory Diseases • Sleep Disorder • Type 2 Diabetes Mellitus

'Korean-style obesity drug' to be launched next year···Hanmi Pharmaceuticals to conduct phase 3 new drug trial [Google translation] (Nate) - "According to industry sources on the 4th, Hanmi Pharmaceutical plans to commercialize its obesity drug candidate 'Efpeglenatide', which is currently undergoing domestic phase 3 clinical trials, by the second half of 2026. This is about half a year earlier than the original target date of the first half of 2027....In addition, 'HM17321', which shows a weight loss effect similar to Wegovy and Mounjaro while also increasing muscle, is scheduled to enter phase 1 clinical trials in the second half of this year."

Launch • New P1 trial • Obesity

Efficacy and Safety of Efpeglenatide in Patients With Type 2 Diabetes and Obesity: A Systematic Review. (PubMed, Cureus) - "Future research should focus on cardiovascular outcomes, long-term safety, and improvements in quality of life to fully assess the benefits of efpeglenatide. In conclusion, efpeglenatide is a promising treatment for T2DM and obesity, offering effective glycemic control, weight reduction, cardiovascular and renal benefits, a favorable safety profile, and convenient dosing."

Journal • Review • Cardiovascular • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Comparison of the efficacy and safety of GLP-1 receptor agonists on cardiovascular events and risk factors: A review and network meta-analysis. (PubMed, Diabetes Obes Metab) - "This study compared the cardiovascular benefits of different GLP-1RAs, including reductions in cardiovascular events and improvements in multiple cardiovascular risk factors. However, due to limitations in the quantity and quality of the included studies, the conclusions should be interpreted with caution. Future large-scale, high-quality clinical trials are needed to validate these findings and further optimize comprehensive cardiovascular management strategies for patients."

Journal • Retrospective data • Review • Cardiovascular • Dyslipidemia • Gastrointestinal Disorder

A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Impact of baseline FIB-4 score on efpeglenatide benefits on cardiovascular outcomes in people with type 2 diabetes: a participant-level exploratory analysis of the AMPLITUDE-O trial. (PubMed, Cardiovasc Diabetol) - "In high-risk people with type 2 diabetes, the degree of liver fibrosis, as estimated by FIB-4 score, was not related to incident cardiovascular outcomes. The beneficial effect of efpeglenatide on these outcomes is independent of FIB-4 category."

Biomarker • Clinical • Journal • Cardiovascular • Diabetes • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Do nonglycaemic effects such as weight loss account for HbA1c lowering with efpeglenatide?: Insights from the AMPLITUDE-O trial. (PubMed, Diabetes Obes Metab) - No abstract available

Journal

Evaluating the impact of efpeglenatide on cardiometabolic and safety outcomes in individuals with diabetes: a systematic review and meta-analysis. (PubMed, J Diabetes Metab Disord) - "Thus, further trials are warranted to comprehensively assess its safety and efficacy to derive a robust conclusion. The online version contains supplementary material available at 10.1007/s40200-024-01409-3."

Journal • Retrospective data • Review • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Glucagon-like Peptide-1 (GLP-1) Receptor Agonists - Efficacy, Safety, and Cost-Effectiveness in Obesity Management: A Systematic Review (ISPOR 2024) - "Weight reduction for those on liraglutide ranged from 0.7 kg in 52 weeks to 8.4 kg in 68 weeks, and reduction in BMI ranged from 1.0 to 4.2 kg/m 2 in 52 weeks...Other GLP-1 agonists (efpeglenatide, tirzepatide, and exenatide) also reported consistent weight reductions ranging from 1.7 to 7.3 kg and a reduction in BMI ranging from 2.3 to 2.6 kg/m 2... GLP-1 receptor agonists promoted weight reduction, improved metabolic parameters and were considered safe, even though they were less cost effective compared with alternative anti-obesity medications."

Clinical • Cost effectiveness • HEOR • Review • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Hanmi Pharmaceutical is reborn as a renowned ‘obesity treatment’ company in metabolic diseases. (eDaily) - "Choi In-young, head of Hanmi Pharmaceutical R&D Center (photo), appeared as a speaker at the Innovative New Drug Salon Songdo held at Incheon Startup Park in Yeonsu-gu, Incheon on the evening of the 13th....Efpeglenatide has secured data from the existing phase 3 clinical trial, and the indication has been changed to an obesity treatment drug and a domestic phase 3 clinical trial is being promoted. It is planned to begin administering the drug to patients next year and complete clinical trials in 2026. If it is launched in Korea in the first quarter of 2027 as planned, it is expected that Korea's first indigenous new drug for obesity will be created."

Launch non-US • New trial • Metabolic Disorders • Obesity

Cardiovascular and renal outcomes with varying degrees of kidney disease in high-risk people with type 2 diabetes: An epidemiological analysis of data from the AMPLITUDE-O trial. (PubMed, Diabetes Obes Metab) - "In high-risk people with diabetes, eGFR, UACR, and KDIGO category have different relationships to incident cardiovascular and kidney outcomes. The beneficial effect of efpeglenatide on these outcomes is independent of kidney-related risk category."

Journal • Cardiovascular • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus (clinicaltrials.gov) - P3 | N=420 | Not yet recruiting | Sponsor: Hanmi Pharmaceutical Company Limited

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Structures of formulations of GLP-1 receptor agonists #exenatide #lixisenatide #efpeglenatide #liraglutide #semaglutide #dulaglutide #albiglutide.

Regulator OKs Hanmi's phase 3 trial of obesity treatment optimized for Koreans (Korea Biomedical Review) - "Hanmi Pharm said the Ministry of Food and Drug Safety (MFDS) has approved its phase 3 clinical trial plan for efpeglenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, to treat obesity. After submitting an investigational new drug (IND) application to the MFDS in July, Hanmi was able to secure speedy approval for the study through various support programs run by the ministry."

New P3 trial • Metabolic Disorders • Obesity

Safety and Efficacy of Efpeglenatide in Patients With Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Cureus) - "A total of four studies fulfilled the inclusion and exclusion criteria and were included in this meta-analysis, encompassing six randomized controlled trials (RCTs). Compared with a control group, efpeglenatide lowered the HbA1c (mean difference (MD): -0.81, 95% confidence interval (CI): -1.01 to -0.60), body weight (MD: -1.15, 95% CI: -1.82 to -0.47), and FSG (MD: -0.98, 95% CI: -1.19 to -0.77). However, the risk of GI-related adverse events was significantly higher in the efpeglenatide group compared to the control group."

Journal • Retrospective data • Review • Diabetes • Gastrointestinal Disorder • Metabolic Disorders • Type 2 Diabetes Mellitus

Overview of Recent Systematic Literature Reviews on Glucagon-like Peptide-1 Receptor Agonists for Weight Loss in Adults with Obesity (ISPOR-EU 2023) - "The most commonly assessed GLP-1 RA was liraglutide (85%), followed by semaglutide (43%), exenatide (34%), and dulaglutide (13%). Lixisenatide (9%), efpeglenatide (6%), albiglutide (2%), and tirzepatide (2%), were also identified... Recent SLRs reflect the growing number of GLP-1 RAs, which uniquely target both peripheral and brain mechanisms involved in weight regulation. GLP-1 RAs show promise as efficacious and safe pharmacological treatment for obesity; however, the long-term benefits are not yet known. Subsequent SLRs are needed to synthesize evidence on newer AOMs, including dual receptor agonists such as tirzepatide, once data are published."

Clinical • CNS Disorders • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Polycystic Ovary Syndrome • Psychiatry • Schizophrenia

Efpeglenatide and Clinical Outcomes with and without Concomitant Sodium-Glucose Co-Transporter-2 Inhibition Use in Type 2 Diabetes (AMPLITUDE-O Trial) (AHA 2022) - "There is no abstract associated with this presentation."

Clinical • Clinical data • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of Glp-1 Receptor Agonists on Systolic Blood Pressure in Patients With Overweight or Obesity: A Network Meta-Analysis (AHA 2022) - "We conducted a network meta-analysis to evaluate the effect of different drug-dose combinations of GLP-1 RAs on SBP in this population. Electronic databases were searched through January 2022 for RCTs which evaluated the efficacy of different doses of semaglutide, liraglutide, efpeglenatide, and exenatide in obese patients with and without T2DM... This network meta-analysis suggests liraglutide <2mg QD is the most efficacious GLP-1 RA in lowering SBP in obese patients with T2DM. For obese patients without diabetes, efpeglenatide ≤6mg QW is the most effective."

Retrospective data • Cardiovascular • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus