HK inno.N announced on October 31 that it has submitted an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety (MFDS) for a Phase 3 clinical trial of its obesity treatment candidate IN-B00009.

The trial will involve 384 adult patients with obesity or overweight without diabetes. Conducted across multiple centers, including Kangbuk Samsung Hospital, the study will follow a randomized, double-blind, placebo-controlled, parallel-group design.

IN-B00009 is a GLP-1 receptor agonist (GLP-1 RA) being developed by HK inno.N for indications including type 2 diabetes, obesity, and metabolic dysfunction-associated steatotic hepatitis (MASH). The drug is currently in Phase 3 trials in China for obesity and diabetes, having already completed Phase 1 trials in Australia and Phase 2 trials in Australia, New Zealand, and China.

The upcoming Phase 3 trial in South Korea is set to run from April 2024 to March 2028, spanning three years. The primary objective is to demonstrate the superiority of IN-B00009 in weight reduction compared to placebo and to evaluate its safety profile. The drug will be administered as a once-weekly subcutaneous injection.

HK inno.N stated that it will promptly disclose further updates upon regulatory approval of the clinical trial.

Currently, approved GLP-1 RA treatments for obesity include Novo Nordisk's Saxenda (liraglutide) and Wegovy (semaglutide), as well as Eli Lilly’s Zepbound and Mounjaro (tirzepatide). With IN-B00009, HK inno.N aims to compete in the rapidly growing global market for obesity treatments.

This submission marks a significant step in HK inno.N’s efforts to advance innovative treatments for metabolic disorders and strengthen its presence in the obesity therapeutics landscape.