Novo Nordisk’s next-gen obesity drug enters Korean trials

MFDS approves multinational Phase IIIa·IIIb studies of amycretin… dual-agonist

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Novo Nordisk, the developer of the obesity treatment Wegovy (semaglutide), will conduct multinational Phase III clinical trials for its next-generation obesity therapy in Korea.

The candidate is amycretin, the company’s next-generation obesity treatment candidate , with the company aiming for global commercialization through multinational trials.

On the 24th, the Ministry of Food and Drug Safety (MFDS) approved two Investigational New Drug (IND) applications for Novo Nordisk’s NNC0487-0111.

One is a Phase IIIa trial (AMAZE 2) evaluating the efficacy and safety of once-weekly NNC0487-0111 s.c. in subjects with overweight or obesity and type 2 diabetes. The other is a Phase IIIb clinical trial (HF-POLARIS) evaluating the efficacy and safety of NNC0487-0111 versus placebo on morbidity and mortality in patients with obesity and heart failure with preserved or mildly reduced ejection fraction.

NNC0487-0111 is the development code for amycretin, which is being developed by Novo Nordisk.

Amycretin is a next-generation obesity treatment with a dual mechanism of action: it stimulates the GLP-1 receptor like Wegovy, while also acting on the pancreatic hormone amylin, which is involved in appetite regulation.

Novo Nordisk is developing amycretin in both a once-weekly injectable formulation and a once-daily oral formulation. In earlier clinical trials, amycretin demonstrated up to 24.3% weight reduction over 36 weeks of subcutaneous administration.

Based on these results, Novo Nordisk plans to conduct a multinational Phase III trial starting this year. Commercialization is expected after 2028. South Korea is included in the global, multi-national Phase III trial network.

In Korea, the planned enrollment is 155 patients for HF-POLARIS (global total: 5,610) and 60 patients for AMAZE 2 (global total: 630).

HF-POLARIS will be conducted at Wonju Severance Christian Hospital, Seoul National University Hospital, Chungnam National University Hospital, Gachon University Gil Medical Center, Pusan National University Yangsan Hospital, Inha University Hospital, Ajou University Hospital, Samsung Medical Center, Severance Hospital (Sinchon), Seoul National University Bundang Hospital, Keimyung University Dongsan Medical Center, Seoul St. Mary’s Hospital, Korea University Ansan Hospital, Seoul Asan Medical Center, and Hallym University Sacred Heart Hospital.

AMAZE 2 will take place at Kyung Hee University Medical Center, Chonnam National University Hospital, Seoul Asan Medical Center, Seoul National University Hospital, Seoul National University Bundang Hospital, Yeouido St. Mary’s Hospital, and Severance Hospital (Sinchon).

Novo Nordisk’s development of amycretin is viewed as a strategic move to maintain competitiveness in the GLP-1 obesity treatment market.

In Korea, Wegovy and Eli Lilly’s Mounjaro have formed a two-horse race. Wegovy, approved by the MFDS in 2023, recorded domestic sales of KRW 467 billion last year, according to IQVIA.

Mounjaro, which targets both GIP and GLP-1 receptors, was launched in Korea in the second half of last year and generated KRW 215.5 billion in sales. The two companies continue to compete globally, including through the development of oral obesity treatments.