HM15275 / Hanmi - LARVOL DELTA

Daol Securities lifts Hanmi Pharma target as obesity pipeline gains value (Chosun Biz) - "Lee Ji-su, an analyst at Daol Investment & Securities, said, 'HM17321 (LA-UCN2) is a peptide therapy that targets fat reduction and muscle gain at the same time. 'Lee also saw expectations rising for the follow-up obesity treatment pipeline, the triple agonist HM15275 (LA-TRIA)....Lee said, 'HM15275 is expected to complete phase 2 in the first half of next year,' and analyzed, 'if the favorable tolerability and weight-loss effect confirmed in phase 1 are also demonstrated in phase 2, expectations for additional technology transfer will expand significantly.'"

Commercial • Trial completion date • Obesity

Therapeutic Potential of HM15275, a Long-Acting GLP-1/GIP/Glucagon Triple Agonist, for Dyslipidemia (OBESITY WEEK 2026) - No abstract available

Dyslipidemia • Metabolic Disorders

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hanmi Pharma completes US phase 2 enrollment for GLP-1 triple agonist 'HM15275' in four months (BioNews) - "The trial is being conducted across 14 research institutions in the United States alone, and its completion is anticipated in January 2027....This Phase 2 clinical trial is designed to evaluate the efficacy of HM15275. Hanmi Pharmaceutical has defined the primary endpoint as the percentage change in body weight from Week 1 to Week 37, measured under fasting conditions using a standardized scale."

Enrollment closed • Trial completion date • Obesity

Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Hanmi Pharmaceutical Company Limited

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus (clinicaltrials.gov) - P2 | N=267 | Active, not recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Recruiting ➔ Active, not recruiting

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

Hanmi Pharmaceutical said on the 2nd that it completed the first patient dosing in a U.S. phase 2 trial of the triple agonist "HM15275." (Chosun Biz) - "The trial is expected to conclude in the first half of next year....The target for commercialization is 2030."

Launch US • Trial status • Obesity

Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Not yet recruiting ➔ Recruiting

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

Hanmi Pharmaceutical also announced additional analyzes from a Phase 1 clinical trial, confirming the favorable safety and tolerability of HM15275, along with pharmacokinetic properties indicative of sustained long-term therapeutic efficacy (BioNews) - "In addition to the previously reported weight reduction, improved glycemic control, and an acceptable safety profile, the company also presented new data on lipid profile and immunogenicity assessments."

P1 data • Obesity

Efficacy and Safety of HM15275, a Novel Long-Acting Triple Agonist in Adults With Obesity (OBESITY WEEK 2025) - "HM15275 demonstrated a safety and tolerability profile comparable to other incretin-based therapies, with pharmacokinetics supporting weekly administration. Preliminary efficacy data, including weight loss and glycemic control, suggest the therapeutic potential of HM15275 in obesity and metabolic diseases including type 2 diabetes mellitus. These findings warrant further development of HM15275 with a long-term, high-dose regimen."

Clinical • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • GCG

A Phase 2 Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: Hanmi Pharmaceutical Company Limited

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

Mechanistic insights into the potent anti-obesity effects of HM15275, a novel long-acting GLP-1/GIP/glucagon triple agonist (EASD 2025) - "SEMA, TZP, and/or in-house synthesized retatrutide (RETA) served as comparative controls. In DIO mice, a 3-week treatment with HM15275 resulted in greater BWL (-39.9% vs. baseline) compared to SEMA (-14.9%) and TZP (-25.3%). In DIO mice, HM15275 demonstrated BWL primarily driven by fat mass reduction, with greater effects than other incretin drugs. In addition, comprehensive MoA studies elucidated the underlying mechanism for its potent BWL. These findings highlight the potential of HM15275 to enable both quantitatively and qualitatively improved obesity management."

Metabolic Disorders • Obesity • GCG

Robust Antiobesity Effect and Mechanistic Insights of HM15275, a Novel Long-Acting GLP-1/GIP/Glucagon Triple Agonist in Animal Model of Obesity (ADA 2025) - "Tirzepatide (TZP) and retatrutide (RETA, in-house synthesis) served as comparative controls. In DIO mice, HM15275 treatment for 3 weeks resulted in a greater weight loss (-39.9% vs. D0) than TZP (-25.3% vs. D0). In conclusion, HM15275 demonstrates potent weight loss with improved weight loss quality in DIO mice. Also, comprehensive elucidation of the underlying mechanism of action has been demonstrated. Clinical translation of such findings is under investigation in an ongoing phase 1, 4-week multiple ascending dose (MAD) study in obese patients."

Preclinical • Metabolic Disorders • Obesity

Safety, Tolerability, and Pharmacokinetics of HM15275, a Novel GLP-1, GIP, and Glucagon Triple Receptor Agonist—Preliminary Results from a Phase 1 Study (ADA 2025) - "HM15275 was well tolerated up to 4 mg, with no SAEs and a safety profile consistent with incretin therapies. PK supports weekly dosing. Findings suggest clinically meaningful early weight loss, warranting further evaluation for long-term efficacy and durability in obesity and CVRM disease."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Metabolic Disorders • Obesity

A Novel UCN2 Analog HM17321 with HM15275 Improves Body Composition in Mouse Model of Obesity (ADA 2025) - "The combination of HM17321 and HM15275 resulted in enhanced fat reduction while preserving lean mass, indicating improved body composition during weight loss. These findings suggest that HM17321 could be a promising therapeutic option in combination strategies for treating obesity."

Preclinical • Metabolic Disorders • Obesity

Metabolic Adaptation of Liver with Treatment of HM15275, a Long-Acting GLP-1/GIP/Glucagon Triple Agonist, Supporting Lean Mass Preservation (ADA 2025) - "Previous nonclinical studies demonstrated that HM15275 achieved superior WLQ compared to Tirzepatide (TZP), a GLP-1/GIP dual agonist. HM15275 induces significant metabolic adaptations in liver, explaining improved WLQ compared with TZP. By preserving fat metabolism, suppressing amino acid catabolism, and enhancing gluconeogenesis and lactate recycling, HM15275 promotes greater fat mass loss with preserving lean mass. Furthermore, by prioritizing glucose generation over ketogenesis, HM15275 supports efficient energy metabolism without causing glucose intolerance."

Metabolic Disorders • Obesity

Domestic pharmaceutical companies release latest clinical data in US ADA [Google translation] (Money Today Network (MTN)) - P1 | N=74 | NCT06481098 | Sponsor: Hanmi Pharmaceutical Company Limited | "In particular, the results of the phase 1 clinical trial of HM15275 were disclosed for the first time, drawing attention. HM15275 is attracting attention as a treatment that can overcome 'muscle loss', a limitation of existing GLP-1 series obesity drugs...The phase 1 clinical trial results confirmed good safety and tolerability as well as pharmacodynamic characteristics supporting long-term sustainability. In particular, the highest dose group (0.5-2-4-8mg) of the 4-week repeated administration in phase 1 showed an average weight loss of 4.81% compared to the placebo on day 29 after the 4th administration...In addition, participants who showed the maximum weight loss after 4 weeks of administration showed a weight loss of 10.64% on day 43."

P1 data • Obesity

Metabolic Adaptation of Liver with Treatment of HM15275, a Long-Acting GLP-1/GIP/Glucagon Triple Agonist, Supporting Lean Mass Preservatio (Abstract Number: 7 55-P) [Google translation] (163.com) - "We performed RNA sequencing of livers of DIO mice treated with HM15275 or TZP for 11 days, and identified affected biological processes using gene set variation analysis (GSVA) ​​and the MSigDB database, including Hallmark, KEGG, Reactome, Wikipathways, and Gene Ontology....The results suggest that HM15275 maintains fat metabolic pathways, including fatty acid β-oxidation and transport, which are downregulated under TZP treatment, which helps achieve greater fat mass loss under fasting-related metabolic challenges. Compared with TZP, HM15275 inhibits amino acid catabolism pathways, which helps retain lean body mass. Enrichment analysis found that HM15275 activated glucose production-related pathways such as gluconeogenesis and lactate cycle more significantly than TZP, but fasting blood glucose was still lower than that of the control group, suggesting that it has limited effect on glucose tolerance."

Preclinical • Obesity

Pushing the Boundaries of GLP-1 Innovation ― Hanmi to Present Six Obesity Drug Studies at ADA 2025 (Hanmi Press Release) - "Hanmi Pharmaceutical to Unveil Six Research Updates on HM15275 and HM17321 at ADA 2025; Phase 1 Results of Next-Generation Triple Agonist HM15275 to Be Unveiled for the First Time; Phase 2 Initiation Targeted for Second Half of 2025."

Clinical data • New P2 trial • P1 data • Obesity

HM-OBCT-101: A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects. (clinicaltrials.gov) - P1 | N=74 | Completed | Sponsor: Hanmi Pharmaceutical Company Limited | Active, not recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ May 2025

Trial completion • Trial completion date • Genetic Disorders • Obesity

[Report Briefing] Hanmi Pharmaceutical, 'Momentum recovery expected in the second half' Target price 330,000 won - Kiwoom Securities [Google translation] (Nate) - "'The 1Q25 performance is expected to fall slightly short of market expectations. The presentation of the phase 1 trial of HM15275 (LA-GLP/GIP/GCG) and the preclinical study results of HM17321 (LA-UCN2) are scheduled for the American Diabetes Association (ADA) in June.'"

P1 data • Preclinical • Obesity

Wegovy dominates, but local challengers emerge (Korea Biomedical Review) - "Novo’s ambitions in Korea are perhaps clearest in the obesity market, where GLP-1 drug Wegovy (semaglutide) is already seeing breakout demand. Sales hit 8.87 billion won ($6.19 million) in the first two months of 2025—nearly half its 2024 full-year total of 18.46 billion won....A triple agonist, HM15275, is entering phase 2 in the second half of this year, while HM17321, designed to preserve muscle mass during weight loss, is slated for phase 1 in 2026."

New P1 trial • New P2 trial • Sales • Obesity

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

HM-OBCT-101: A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects. (clinicaltrials.gov) - P1 | N=90 | Active, not recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Hanmi Pharmaceutical's 'Obesity Drug' Expected to Transfer Technology Overseas... Aiming for a Rebound [Google translation] (Money Today) - "According to the industry, Hanmi Pharmaceutical is expected to disclose the US phase 1 clinical data of 'HM15275' (LA-TRIA), a triple agonist for obesity treatment...at the American Diabetes Association (ADA) in June. The preclinical data of 'HM17321' (LA-UCN2), another major pipeline of the company, is also expected to be presented at the conference....It has been reported that Hanmi Pharmaceutical held meetings with overseas pharmaceutical companies regarding HM15275 and HM17321 during the 'JP Morgan Healthcare Conference' held last month. As overseas competing products have minimal weight loss effects compared to muscle gain effects, there are high expectations that active discussions on technology transfer for both monotherapy and combination therapies in Hanmi Pharmaceutical's pipeline will continue."

Commercial • P1 data • Preclinical • Obesity