HK inno.N Receives Phase 3 Approval for Once-Weekly Obesity Drug

[Kim Jinsoo, Edaily Reporter] HK inno.N is set to begin a Phase 3 clinical trial for its investigational obesity treatment. On May 8, the company announced that it had received Investigational New Drug (IND) approval from South Korea’s Ministry of Food and Drug Safety on May 7 to begin domestic Phase 3 trials of “IN-B00009” (ingredient name: ecnoglutide), a glucagon-like peptide-1 receptor agonist (GLP-1 RA).

(HK inno.N)

The Phase 3 study will target adults with obesity or who are overweight without diabetes. Participants will receive either IN-B00009 or a placebo as a once-weekly subcutaneous injection, with the trial designed to evaluate the drug’s efficacy and safety. The trial is structured as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study and is expected to be completed by May 2028.

Primary endpoints include percentage change in body weight from baseline at week 40 and the proportion of participants achieving at least 5% weight loss. IN-B00009, a GLP-1 receptor agonist, previously demonstrated statistically significant weight loss and safety compared to liraglutide after 26 weeks of treatment in a Phase 2 trial conducted in Australia and New Zealand. It also showed superior weight loss over placebo in a Phase 3 study involving Chinese patients with obesity.

According to the 2024 “Obesity Fact Sheet” published by the Korean Society for the Study of Obesity, the prevalence of obesity among South Korean adults reached 38.4% in 2022 and has been steadily increasing for both men and women over the past decade. Globally, the rising prevalence of obesity is accelerating the development of obesity treatments.

The global obesity drug market was valued at $19.04 billion in 2023 and is projected to grow at a compound annual growth rate of 14.4%, reaching $37.37 billion by 2028.

“We are dedicating all our resources to ensure IN-B00009 contributes to treating obesity, a global disease,” an HK inno.N spokesperson said.

IN-B00009 is a compound HK inno.N licensed in from China-based Sciwind Biosciences in 2024. The company holds domestic development and commercialization rights and is developing the compound as both an obesity and diabetes treatment.