HK inno.N is set to begin a Phase 3 clinical trial in South Korea for its obesity treatment candidate, IN-B00009, a GLP-1 receptor agonist. The company submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety, signaling a significant step in the drug's development. This trial aims to evaluate the efficacy and safety of IN-B00009 in adult patients who are obese or overweight but do not have diabetes.
Trial Design and Objectives
The Phase 3 study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. It will involve 384 participants across multiple medical centers, including Kangbuk Samsung Hospital. The trial is scheduled to run from April 2025 to March 2028. The primary objective is to demonstrate the superiority of IN-B00009 in promoting weight loss compared to a placebo. Secondary objectives include assessing the drug's safety profile.
IN-B00009: A GLP-1 Receptor Agonist
IN-B00009 (ecnoglutide) is a GLP-1 RA drug being developed for the treatment of type 2 diabetes, obesity, and MASH (metabolic-associated steatohepatitis). It is administered via subcutaneous injection once a week. HK inno.N entered into a licensing and partnership agreement with Sciwind Bioscience for the development and commercialization of ecnoglutide in Korea. Ecnoglutide is currently in Phase 3 clinical trials in China for both type 2 diabetes and obesity, with earlier Phase 2 trials in China and Australia showing promising results in reducing blood sugar levels and promoting weight loss.
Current Market Landscape
The obesity treatment market includes established GLP-1 RA drugs such as Novo Nordisk's Saxenda (liraglutide) and Wegovy (semaglutide), as well as Eli Lilly's Zepbound and Mounjaro (tirzepatide). HK inno.N's IN-B00009 aims to provide another option for patients struggling with obesity, addressing a significant global health challenge.
