Novo Nordisk Initiates Phase III Trial of CagriSema for Weight Management in East Asian Populations

On April 14, the clinicaltrials.gov website showed that Novo Nordisk launched a Phase III clinical trial to evaluate the weight loss effects of CagriSema (Cagrilintide + Semaglutide) compared to Semaglutide in overweight populations in East Asia. Click "Read the original text" to view the detailed information of this study.

This study is a multicenter, blinded, randomized, positive drug-controlled clinical trial conducted in Japan and Taiwan, China, planning to enroll 330 overweight adult subjects who either ① have a Body Mass Index (BMI) ≥27kg/m² and are accompanied by two or more obesity-related complications, or ② have a BMI ≥35kg/m² and are accompanied by one or more obesity-related complications. Novo Nordisk expects this study to be completed by March 2025.

Enrolled subjects will be divided into 2 cohorts: ①CagriSema (2.4mg Cagrilintide + 2.4mg Semaglutide) and ②2.4mg Semaglutide + Semaglutide Placebo. The treatment will last for 68 weeks, including a 16-week dose escalation period and a 52-week dose maintenance period.

The primary endpoint of the study was the percentage change in subjects' weight from baseline at Week 68. Secondary endpoints included the percentage change in subjects' weight from baseline at Week 20, the proportion of subjects with ≥20% weight loss at Week 68, changes in waist circumference, and changes in visceral fat area (VFA), among others.

CagriSema is a combination therapy developed by Novo Nordisk, consisting of the amylin analog Cagrilintide and the GLP-1R agonist Semaglutide. In August 2022, Novo Nordisk announced the Phase II study results of CagriSema for the treatment of type 2 diabetes. The data showed that compared to the Cagrilintide group (-0.93%) and the Semaglutide group (-1.79%), the HbA1c levels in the CagriSema group decreased by 2.18%. Additionally, CagriSema also demonstrated significant weight loss effects (CagriSema vs Cagrilintide vs Semaglutide: -15.6% vs -8.1% vs -5.1%).

Based on the results of this Phase II study, Novo Nordisk launched the global Phase III clinical trial (REDEFINE 1) for CagriSema in weight management in November 2022. In 2023, a global Phase III study (REDEFINE 2) for patients with type 2 diabetes who are obese or overweight and a global Phase III study (REDEFINE 3) for obese individuals with cardiovascular disease were also initiated.

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