HK inno.N speeds up developing homegrown obesity drug

HK inno.N has submitted an IND (investigative new drug) plan for a phase 3 clinical trial of a GLP-1 receptor agonist (GLP-1 RA) for treating obesity, drawing the industry’s interest.

The company said Tuesday that it has presented a phase 3 IND for its obesity treatment candidate IN-B00009 to the Ministry of Food and Drug Safety.

The phase 3 study will be conducted on 384 adult obese or overweight patients without diabetes. It will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted at multiple medical centers, including Kangbuk Samsung Hospital.

IN-B00009 is a GLP-1 RA drug being developed by HK in no.N for treating type 2 diabetes, obesity, and MASH (metabolic-associated steatohepatitis). According to the company, it is currently in a phase 3 clinical trial in China for obesity and diabetes, having completed phase 1 in Australia and phase 2 in Australia, New Zealand, and China.

Phase 3 is expected to run for three years, from April 2025 to March 2028. The trial's objectives are to demonstrate the superiority of IN-B00009 in weight loss compared to placebo and to evaluate safety. The drug will be administered by subcutaneous injection once a week.

HK inno.N said it would file the relevant disclosures once the protocol is approved.

Currently, commercialized GLP-1 RA drugs for obesity indications include Novo Nordisk's Saxenda (liraglutide) and Wegovy (semaglutide) and Eli Lilly's Zepbound and Mounjaro (tirzepatide).