HK inno.N said it has received approval from the Ministry of Food and Drug Safety to begin a phase 3 clinical trial of its investigational obesity treatment, IN-B00009 (ingredient: ecnoglutide), a glucagon-like peptide-1 receptor agonist (GLP-1 RA).

HK inno.N in-licensed IN-B00009 in 2024 from China-based Sciwind Biosciences. The company holds exclusive development and commercialization rights for the drug in Korea and is pursuing its development both as an obesity treatment and a diabetes therapy.

The phase 3 study will evaluate the efficacy and safety of IN-B00009 in 300 overweight or obese adult patients without diabetes. Participants will receive either the investigational drug or a placebo through weekly subcutaneous injections. The trial will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study, with completion targeted for May 2028.

HK inno.N said the trial’s primary endpoints include percentage change in body weight at week 40 from baseline and the proportion of participants achieving at least a 5 percent weight reduction.

IN-B00009 previously demonstrated statistically significant weight loss compared to liraglutide in a 26-week phase 2 trial conducted in Australia and New Zealand. It also showed superior weight reduction compared to placebo in a separate phase 3 trial involving obese patients in China.

“HK inno.N will dedicate all available resources to ensure that IN-B00009 can contribute meaningfully to the treatment of obesity, a growing global health concern,” a company representative said.

Meanwhile, according to the Obesity Fact Sheet 2024, published by the Korean Society for the Study of Obesity, the prevalence of obesity among Korean adults reached 38.4 percent as of 2022, reflecting a steady rise over the past decade across both genders.