Novo Nordisk opens a Korean Phase 3 trial of CagriSema

Novo Nordisk has started enrolling patients in South Korea for a Phase 3 trial of CagriSema, its experimental weekly injection that combines cagrilintide 2.4 mg with semaglutide 2.4 mg. South Korea's Ministry of Food and Drug Safety approved the trial application on Aug. 26, and the study will enroll about 400 overweight or obese adults across seven hospitals, including Seoul National University Hospital and Severance Hospital ^[1]. The main goal is to measure percent change in body weight at 80 weeks ^[1].

CagriSema pairs two hormone pathways in one shot. Semaglutide is the same GLP-1 molecule sold as Ozempic and Wegovy. Cagrilintide mimics amylin, a hormone that works alongside insulin to curb appetite. Novo is also developing an oral version ^[1]. In an earlier 36-week Phase 2 study of 262 people with type 2 diabetes, the highest weekly dose (40 mg) produced average weight loss of 14.6%, compared with 2.1% for placebo, and lowered blood sugar markers (HbA1c) by 1.71 percentage points ^[1]. Gastrointestinal side effects such as nausea were the most common problem and were mostly mild to moderate ^[1].

The Korean trial is separate from the US regulatory decision. Novo submitted a New Drug Application to the FDA in December 2025 based on the REDEFINE 1 trial, a 68-week study of 3,417 adults without diabetes, in which CagriSema produced weight loss up to 22.7% ^[2]. A company filing with US securities regulators in the second quarter of 2026 pointed to a decision in the fourth quarter of 2026, though as of July 2026 neither the FDA nor Novo had confirmed an exact decision date ^[2].

That data sits alongside a less favorable result. In the separate REDEFINE 4 trial, an 84-week head-to-head study, CagriSema failed to show it worked as well as Eli Lilly's tirzepatide (Zepbound) at its highest 15 mg dose — patients on tirzepatide lost more weight ^[2]. For comparison, Wegovy has produced average weight loss near 14.9% over 68 weeks in earlier trials, while Zepbound's highest dose produced 20.9% over 72 weeks in a similarly designed study ^[1]. Novo has since started planning a higher-dose version of CagriSema, with a new Phase 3 trial of that formulation expected to begin in the second half of 2026 and results from a broader trial, REDEFINE 11, expected in the first half of 2027 ^[2].

Why it matters for patients

For US patients, nothing changes immediately. CagriSema is not approved anywhere and is not available by prescription. The Korean study is a step toward gathering data in Asian populations, which regulators sometimes require, but it does not by itself speed up or slow down the US timeline ^[1].

The more relevant fact for patients weighing options today is the mixed trial record. CagriSema showed strong weight loss compared with placebo, but it did not beat tirzepatide in a direct comparison, which could affect how it is positioned relative to Zepbound and Mounjaro if it reaches the market ^[2]. Patients considering existing GLP-1 drugs, or waiting on new ones, may want to know that comparative results, not just placebo-controlled numbers, matter when judging how well a drug is likely to work for them specifically.

What happens next

A US decision on CagriSema is expected in the fourth quarter of 2026, though no specific date has been confirmed ^[2]. Data from the REDEFINE 11 trial, which is examining CagriSema's fuller weight-loss potential, is expected in the first half of 2027 ^[2]. No submission to European or UK regulators for weight management has been confirmed ^[2]. The Korean Phase 3 trial's own results were not given a specific reporting date in available materials ^[1].