Novo Nordisk opens Korean Phase 3 trial of CagriSema in Asian adults

Novo Nordisk won approval from South Korea's Ministry of Food and Drug Safety on August 26, 2026, to run a Phase 3 trial of CagriSema in overweight or obese Asian adults, and Korean hospitals are beginning to enroll participants ^[1]. The study is designed for about 400 adults with a primary endpoint of percentage change in body weight at week 80 ^[1].

Seven Korean hospitals are listed as trial sites: Kyungpook National University Hospital, Pusan National University Yangsan Hospital, Konkuk University Medical Center, Ajou University Hospital, Seoul National University Bundang Hospital, Yonsei University College of Medicine Severance Hospital, and Seoul National University Hospital ^[1]. A separate cardiovascular study of CagriSema is also under way in Korea with regulatory approval ^[1]. Nothing in the Korean filings indicates when the 80-week trial is expected to finish ^[1].

The sources describe what CagriSema is in two different ways. One account calls it a dual agonist that stimulates GLP-1 and amylin receptors with a single peptide molecule ^[1]. Another describes it as a fixed-dose combination of cagrilintide 2.4 mg, a long-acting amylin analog, and semaglutide 2.4 mg, the GLP-1 receptor agonist sold as Ozempic, Wegovy and Rybelsus, given as a once-weekly subcutaneous injection ^[2]. That difference in how the two mechanisms are delivered has not been resolved in the reporting. Either way, the drug is investigational and is not approved in the US or EU ^[2].

Novo Nordisk submitted a New Drug Application to the FDA on December 18, 2025, based on the REDEFINE 1 trial ^[2]. In REDEFINE 1, a 68-week randomized, double-blind study of 3,417 adults without diabetes who had obesity or overweight plus at least one weight-related complication, CagriSema produced about 22.7% weight loss at 68 weeks ^[2]. Adults with type 2 diabetes in the program lost up to 15.7% ^[2]. The company's own regulatory pipeline filing with the US SEC in the second quarter of 2026 points to a US decision in the fourth quarter of 2026 ^[2]. As of July 2026, neither the FDA nor Novo Nordisk had publicly confirmed a PDUFA action date ^[2].

The head-to-head result is less favorable. REDEFINE 4, an 84-week open-label Phase 3 trial, did not meet its primary endpoint of showing non-inferiority on weight loss for CagriSema compared with tirzepatide 15 mg, the dose sold as Zepbound; patients on tirzepatide had greater weight loss ^[2]. Earlier data also differ in design from marketed products. In a 36-week Phase 2 study of 262 patients with type 2 diabetes, the highest weekly subcutaneous dose of 40 mg produced a mean weight reduction of 14.6%, compared with 2.1% for placebo, and glycated hemoglobin fell 1.71 percentage points; gastrointestinal symptoms were the most common side effects and were mostly mild to moderate ^[1]. The same report notes these results cannot be compared directly with marketed obesity drugs because the trial populations, durations and designs differ ^[1]. For context, Wegovy showed 14.9% average weight loss over 68 weeks in a Phase 3 trial of overweight or obese patients without diabetes, and Mounjaro showed 20.9% over 72 weeks at the 15 mg dose ^[1].

Why it matters for patients

No CagriSema product is available for prescription in the United States today ^[2]. If the FDA approves it in the fourth quarter of 2026, it would become the first licensed combination of a GLP-1 receptor agonist and an amylin analog ^[2]. The REDEFINE 4 miss against tirzepatide means the drug's place relative to Zepbound would depend on how regulators and prescribers weigh its placebo-controlled results against that head-to-head outcome ^[1][2].

The gastrointestinal side effect profile of GLP-1 receptor agonists — nausea, vomiting and diarrhea — is well documented, and one analysis flags how adding an amylin component affects that profile as something the FDA review will examine ^[2]. The Korean trial adds data from Asian adults, a population that has been less represented in the existing REDEFINE studies ^[1][2].

What happens next

An FDA decision on the CagriSema New Drug Application is expected in the fourth quarter of 2026, based on company guidance ^[2]. A Phase 3 trial of a higher-dose CagriSema formulation is planned to start in the second half of 2026, and the REDEFINE 11 trial is expected to report data in the first half of 2027 ^[2]. Novo Nordisk has not confirmed an European Medicines Agency submission for weight management, and no UK MHRA pathway has been announced ^[2].