HK inno.N Submits Phase 3 Trial Investigational New Drug Application For Obesity Drug IN-B00009

HK inno.N has taken a significant step in obesity treatment by submitting an Investigational New Drug (IND) application for a phase 3 clinical trial of its GLP-1 receptor agonist, IN-B00009. The company has announced that the Phase 3 IND application was submitted to Korea’s Ministry of Food and Drug Safety. 

The phase 3 trial will involve 384 adults who are obese or overweight but do not have diabetes. The study will be a multicenter, randomised, double-blind, placebo-controlled, and parallel group design, and the trial will be conducted at locations like Kangbuk Samsung Hospital. IN-B00009 is being developed as a treatment for type 2 diabetes, obesity, and metabolic-associated steatohepatitis (MASH). 

The drug has previously completed phase 1 trials in Australia and phase 2 trials in Australia, New Zealand, and China. A phase 3 study is currently on the way in China for both obesity and diabetes indications. The upcoming Korean trial is expected to run in the duration of April 2025 to March 2028. 

The study will focus on evaluating the drug's ability to reduce weight compared to a placebo and its safety profile. Participants will receive a once-weekly subcutaneous injection of the drug. HK inno.N has stated that additional information will be provided once the trial protocol gains approval.

The GLP-1 receptor agonist drugs approved for obesity treatment include Saxenda and Wegovy (by Novo Nordisk) and Zepbound and Mounjaro (by Eli Lilly), placing IN-B00009 in a competitive and promising market.