Novo Nordisk has started a clinical trial of semaglutide, a second-generation treatment for obesity after Saxenda (liraglutide), tailored for the Korean population. Saxenda is the leading obesity treatment in Korea in terms of sales.

On Sept. 30, the Ministry of Food and Drug Safety approved a phase 3b study of semaglutide injection 2.4mg (U.S. brand: Wegovy).

The double-blind, randomized, and placebo-controlled study will be on 150 Asian obese patients, testing the efficacy and safety of once-weekly semaglutide 2.4mg.

It is noteworthy that the study targeting Asian patients set the obesity criteria as body mass index (BMI) of 25kg/m2 or more, following the local guidelines.

Of the 150 patients, 85 will be Koreans. This indicates that the trial is nearly customized for the Korean population.

Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA), developed by Novo Nordisk as a follow-up drug to liraglutide.

Just as the company developed liraglutide as a type-2 diabetes treatment in a low dose (brand name: Victoza) and then used a high dose (brand name Saxenda) to treat obesity, the company worked on low-dose semaglutide as diabetes drug Ozempic.

Then, Novo Nordisk completed the phase 3 trial of high-dose semaglutide to treat obesity and won the FDA approval for obesity treatment in June.

High-dose semaglutide reduced an average of 17-18 percent of body weight from baseline after 68 weeks in global phase 3 STEP trials, proving better effect than Saxenda.

However, most STEP studies targeted Westerners, setting the obesity criteria at BMI 30 kg/m2 or more or BMI 27 kg/m2 or more. In addition, the patients were overweight with one or more weight-related comorbidities. Thus, the studies could not be applied to Asians.

To conduct a study for Asians, Novo Nordisk set the obesity criteria as BMI 25 kg/m2 or more, following the domestic standards for an obesity trial. However, the trial for Asian patients set the efficacy evaluation period at 44 weeks, shorter than 68 weeks in global trials.

The upcoming study’s primary endpoint will be 5 percent or more weight loss than baseline at week 44, and secondary endpoints, 10 percent or 15 percent or more weight loss than baseline, and changes in waist circumference at week 44.

Professor Lim Soo of endocrinology at Seoul National University Bundang Hospital will lead the trial and plans to complete the study by May 2023.

Novo Nordisk also developed semaglutide as an oral drug and obtained the permit for type-2 diabetes treatment (brand name: Rybelsus) in the U.S. in September 2019.

The company announced a new trial for obesity treatment in April and is conducting a phase 3 study.