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HK inno.N Advances Obesity Drug IN-B00009 to Phase 3 Trial in South Korea

• HK inno.N has filed an IND for Phase 3 clinical trials of IN-B00009, a GLP-1 receptor agonist, targeting obesity treatment in South Korea. • The Phase 3 trial will enroll 384 overweight or obese adults without diabetes, assessing IN-B00009's efficacy and safety over three years. • IN-B00009, licensed from Sciwind Bioscience, is a once-weekly injectable also in Phase 3 trials in China for type 2 diabetes and obesity. • This trial aims to demonstrate IN-B00009's superiority in weight loss compared to placebo, potentially expanding obesity treatment options.

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.
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Reference News

[1]
HK inno.N speeds up developing homegrown obesity drug < Pharma < Article - KBR
koreabiomed.com · Jan 2, 2025

HK inno.N submitted a phase 3 IND for IN-B00009, a GLP-1 RA targeting obesity, to the Ministry of Food and Drug Safety. ...

[2]
HK inno.N seeks approval for domestic phase 3 clinical trial of GLP-1 obesity drug candidate ...
thebionews.net · Jan 2, 2025

HK inno.N filed a phase 3 clinical trial plan for 'IN-B00009,' a GLP-1 obesity treatment, aiming to assess its efficacy ...

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