HM17321 / Hanmi - LARVOL DELTA

A SAD Study of HM17321 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

…Hanmi Pharmaceutical presented three preclinical studies on HM17321, a novel drug engineered to simultaneously promote muscle hypertrophy and lipolysis, thereby achieving what the company describes as 'high-quality weight loss.' (BioNews) - "In addition, Hanmi Pharmaceutical reported that administration of HM17321 in a diet-induced obese animal model promoted muscle growth through activation of the mechanistic target of rapamycin (mTOR) signaling pathway in skeletal muscle....Another study presented by the company demonstrated distinct differences in body composition outcomes between HM17321 and semaglutide in a high-fat diet-induced obese animal model."

Preclinical • Obesity

Discovery of HM17321: A Novel CRFR2 Selective and Biased UCN2 Analog for High-Quality Weight Loss (OBESITY WEEK 2025) - "HM17321, a novel long-acting, CRFR2-selective, and biased UCN2 analog, demonstrates significant potential as next-generation obesity and related metabolic disease medication. The synergy between the mechanistic goals for metabolic improvement and the structural insights into the involved molecules, coupled with the strategic application of AI technologies, led to the design of a promising therapeutic candidate. This seamless integration of computational tools and biological knowledge highlights the significant impact of collaborative approaches in driving progress in drug development."

Genetic Disorders • Metabolic Disorders • Obesity

HM17321 Promotes High-Quality Weight Loss and Improves Metabolic Health in Obesity Treatment (OBESITY WEEK 2025) - "Urocortin-2 (UCN2) has been proposed to promote muscle hypertrophy and lipolysis, which may contribute to improved weight loss quality (WLQ) and whole-body metabolism through the preservation of lean mass. HM17321 demonstrated a unique profile by achieving high-quality weight loss through favorable body re-composition, especially characterized by increased lean mass. In addition, HM17321 provided metabolic benefits such as enhanced energy expenditure and improved glycemic control, supporting the fact that HM17321 enhances not only muscle mass, but also its metabolic functionality. These findings position HM17321 as a promising next-generation therapeutic candidate for obesity and related metabolic disorders, with the potential to be used in combination with incretin-based therapies."

Genetic Disorders • Metabolic Disorders • Obesity

Blood and Muscle Proteomic Analysis Reveals Muscle-Preserving Effects of HM17321 in Mouse Model (OBESITY WEEK 2025) - "HM17321 is a novel corticotropin-releasing factor receptor 2 (CRFR2)-selective and biased urocortin-2 (UCN2) analog that has exhibited dual effects of fat mass loss and lean mass gain in diet-induced obesity (DIO) mouse model. Proteomic analysis in this study suggests that HM17321 directly acts on skeletal muscle to increase muscle mass and improve metabolism, irrelevant with its weight loss effect. These findings highlight its potential to improve the weight loss quality, supporting HM17321 as a next generation therapeutic option for obesity management."

Omic analysis • Preclinical • Genetic Disorders • Obesity

Korea’s Hanmi Pharmaceutical has begun a U.S. phase 1 study after the FDA cleared its investigational new drug application (NDA) for an obesity drug candidate the company says can reduce fat while increasing muscle (Korea Biomedical Review) - "Hanmi said HM17321 has shown preclinical efficacy in overweight and obese nonhuman primate models and is being advanced toward a 2031 launch target."

IND • Launch US • Obesity

A SAD Study of HM17321 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Hanmi Pharmaceutical Company Limited

New P1 trial • Genetic Disorders • Obesity

Hanmi Pharmaceutical said on the 1st that it has submitted a clinical trial plan for the obesity drug HM17321 to the U.S. Food and Drug Administration (FDA). (Chosun Biz) - "The company plans to evaluate safety and tolerability in a phase 1 clinical trial in healthy adults....The goal is commercialization in 2031."

IND • Launch • New P1 trial • Obesity

Efficacy of the novel UCN2 analogue HM17321 in weight loss without muscle wasting in obese non-human primates and its applications with incretins in obese mice (EASD 2025) - "The fat reducing efficacy of HM17321 without muscle wasting was confirmed in non-human obese primates, highlighting its potential as a monotherapy for obesity treatment with human relevance. Along with its human relevance, applications for the best quality in weight loss through various dosing regimens were also confirmed. These findings suggest that HM17321 could be a promising therapeutic option for treating obesity."

Preclinical • Metabolic Disorders • Obesity

A novel CRFR2 selective UCN2 analogue, HM17321, enhances favourable body recomposition, energy expenditure and metabolic health in DIO mice (EASD 2025) - "HM17321 monotherapy uniquely promoted favorable body recomposition by selectively reducing fat mass while increasing lean mass in DIO mice. The body recomposition could directly contribute to the increase in basal metabolic rate (BMR), as evidenced by elevated energy expenditure. Furthermore, HM17321 improved overall metabolic health, reinforcing its potential as a next-generation therapeutic for obesity and metabolic disorders."

Preclinical • Metabolic Disorders • Obesity

Circulating proteomics analysis reveals potential beneficial effects of HM17321 on muscle and bone (EASD 2025) - "HM has demonstrated superior weight loss quality by promoting fat reduction while increasing lean mass, particularly skeletal muscle, in a DIO mouse model. The findings from serum proteomics have supported the beneficial effects on weight loss quality of HM while excluding possible side effects possibly related with HPA and gonadotropin axis. These results suggest that HM not only facilitates effective obesity management but also preserves musculoskeletal health, highlighting its potential as a promising therapeutic strategy for improving body composition and metabolic outcomes."

Metabolic Disorders • Obesity • POMC-null Obesity

Proteomic analysis of skeletal muscle supporting muscle growth and metabolic improvement effects by HM17321 in diet induced obesity mouse model (EASD 2025) - "This study demonstrated how HM17321 effectively promotes fat reduction while preserving and enhancing skeletal muscle mass in DIO mouse model. Proteomic analysis suggests the mechanism of action of HM17321 is mimicking physiologic changes induced by anerobic exercise, which promotes muscle growth, metabolic improvement, as well as weight loss. Together with these findings, HM17321 is a promising therapeutic candidate for obesity management overcoming lean mass loss problem, with the potential to mitigate metabolic risks of obese patients."

Omic analysis • Preclinical • Metabolic Disorders • Obesity

HM17321 Facilitates Weight Loss and Improves Body Composition across Animal Models of Obesity (Hanmi Press Release) - "Hanmi presented new findings demonstrating that HM17321 delivered not only significant weight loss but also meaningful improvements in body composition in animal models, including monkeys...In obese mice and rats, HM17321 induced marked body recomposition effects, including increases in muscle mass that led to elevated basal metabolic rate, indicating that the newly formed muscle was metabolically active and functionally beneficial...Similarly, HM17321 showed consistent results in monkeys, demonstrating robust weight loss alongside improvements in body composition, thereby confirming the compound’s reproducible efficacy across preclinical species....Mechanistic studies further demonstrated that HM17321 promotes lipolysis in human-derived adipocytes and contributes to muscle development by enhancing skeletal muscle cell differentiation. These findings indicate that HM17321 drives both quantitative and qualitative improvements in weight loss."

Preclinical • 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

A Novel CRFR2 Selective UCN2 Analog, HM17321, Facilitates Weight Loss and Improves Body Composition across Animal Models of Obesity (ADA 2025) - "HM17321 demonstrates robust fat mass reduction and lean mass increasing effect across animal models including monkeys. These findings underscore the potential of HM17321 for high quality weight management, supporting its continued development as a differentiated anti-obesity drug."

Preclinical • Metabolic Disorders • Obesity

A Novel CRFR2-Selective UCN2 Analog, HM17321, Improves Glycemic Control across Multiple Preclinical Models (ADA 2025) - "Series of nonclinical evaluations clearly demonstrate improvement effects of HM17321 on glucose tolerance and insulin resistance, which eventually leads to HbA1c lowering effect. These results suggest additional benefits of HM17321 in glycemic control in addition to high quality weight management. Further studies will elucidate the mechanisms by which HM17321 contributes to improved glucose homeostasis, including direct improvement of insulin signaling."

Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

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

[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

'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

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