Hanmi Pharm, a Korean pharmaceutical giant, said on Tuesday that it submitted an investigational new drug (IND) application to the U.S. FDA on March 29 for its next-generation GLP-1/GIP/GCG triple-agonist, named HM15275, to initiate a phase 1 clinical trial targeting obesity.

The trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HM15275 in both healthy adults and those with obesity.

Hanmi Pharm aims to commercialize HM15275 by 2030. 

Earlier on Feb. 29, the company submitted an IND to the Ministry of Food and Drug Safety in Korea.

HM15275, a next-generation obesity drug, is slated to follow efpeglenatide currently undergoing phase 3 trials. 

The new agent aims to enhance the function of glucagon-like peptide (GLP-1), gastric inhibitory peptide (GIP), and glucagon (GCG) receptors, potentially leading to weight loss exceeding 25 percent with minimal muscle loss, according to Hanmi. 

Hanmi Pharm is scheduled to present findings from various studies of HM15275 at the upcoming 2024 American Diabetes Association (ADA) meeting in the U.S. in June.

During the meeting, Hanmi will showcase results illustrating the "best-in-class potential" of HM15275 for weight loss in obesity models, along with its mechanism of action. Additionally, they will present findings demonstrating the distinct therapeutic efficacy of HM15275 in different cardiovascular disease models where obesity plays a significant role.

According to a recent report published by the World Health Organization (WHO) in The Lancet, the global obesity epidemic has doubled, reaching 1 billion people in 2022 from the levels recorded in 1990. Should this trend persist, projections suggest that the worldwide obese population could grow to 1.9 billion by 2035.

Choi In-young, head of the R&D Center at Hanmi Pharm, said, "Based on our long-standing R&D capabilities in the field of metabolic diseases, we are continuously generating new innovative possibilities in the realm of 'obesity,' which is increasingly recognized as a global societal issue."