HK inno.N said on the 22nd that it completed enrollment for a domestic phase 3 clinical trial of the GLP-1 receptor agonist obesity treatment IN-B00009 (ingredient name: ecnoglutide).
According to the company, as of the 20th, enrollment of a total of 313 trial participants was completed. HK inno.N plans to complete approximately 40 weeks of dosing within the year and then begin the regulatory filing process.
HK inno.N received phase 3 investigational new drug (IND) approval for IN-B00009 from the Ministery of Food and Drug Safety in May last year and began the first participant enrollment in September of the same year. Enrollment was completed about four months later.
This phase 3 trial is being conducted at 24 medical institutions in Korea, including Kangbuk Samsung Hospital. Adults with obesity or overweight without diabetes will receive either IN-B00009 or placebo as a once-weekly subcutaneous injection to evaluate efficacy and safety.
The primary endpoints are the percentage change in body weight at week 40 from baseline and the proportion of subjects achieving at least 5% weight loss.
IN-B00009 is a GLP-1 receptor agonist in-licensed by HK inno.N in 2024 from the global biotech Sciwind Biosciences. HK inno.N has secured domestic development and commercialization rights and is developing it as an obesity treatment and a diabetes treatment.