Korea-US, 'Triple Action' Obesity Drug Receives US Phase 1 Clinical Trial Approval

Hanmi Pharmaceutical's next-generation obesity drug HM15275, which aims to minimize 'muscle loss,' a major side effect of obesity treatments, while maintaining weight loss effects, is advancing to clinical Phase 1.

[Photo by Hanmi Pharmaceutical]

Hanmi Pharmaceutical announced on the 7th that it received approval from the U.S. Food and Drug Administration (FDA) on the 3rd (local time) for the Phase 1 clinical trial plan of HM15275. This clinical trial will be conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15275 in healthy adults and obese patients.

HM15275 is a triple agonist (LA-GLP/GIP/GCG) that acts on three receptors: glucagon-like peptide (GLP)-1, which has recently led the global obesity drug market, gastric inhibitory peptide (GIP), and glucagon (GCG). It is designed to specialize in obesity treatment while simultaneously exerting efficacy on various metabolic diseases as a secondary effect.

GLP-1 receptor agonists increase satiety to reduce weight and improve insulin secretion and sensitivity to facilitate blood glucose control. GIP enhances the pharmacological benefits of GLP-1 receptor agonists while alleviating gastrointestinal side effects such as nausea, vomiting, and diarrhea. Glucagon is involved in satiety regulation as well as energy expenditure and lipid metabolism control.

By appropriately utilizing these pharmacological actions, it is explained that the therapeutic potential can be maximized not only for obesity but also for type 2 diabetes and cardiovascular diseases.

Hanmi Pharmaceutical plans to present four preclinical study results on HM15275 at the 2024 American Diabetes Association (ADA) conference held in Florida, USA, from the 21st to the 24th of next month. Through this, they will disclose results that elucidate HM15275’s best-in-class potential within its class, including maintaining weight loss effects while minimizing muscle loss, as well as its mechanism of action. Additionally, they will present results demonstrating HM15275’s differentiated therapeutic efficacy in various cardiovascular disease models known to be primarily caused by obesity.

Choi In-young, Head of Hanmi Pharmaceutical’s R&D Center, said, "HM15275 embodies the accumulated research knowledge and know-how from over 20 years of continuous research in the incretin field at Hanmi Pharmaceutical. We will further devote ourselves to research to complete the development of a next-generation drug that innovatively enhances therapeutic effects in the obesity area, which is emerging as a global social issue."

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