CagriSema Achieves Significant Weight Loss in Phase 3 Trial: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On March 11, 2025, we reported on results from the phase 3 REDEFINE 2 clinical trial examining once-weekly subcutaneous CagriSema (Novo Nordisk) compared to placebo among people with type 2 diabetes (T2D) and obesity or overweight.

The study

REDEFINE 2 enrolled 1206 adults with a mean baseline body weight of 102 kg. The trial utilized a flexible dosing protocol, allowing participants to modify their dosing throughout the trial. After 68 weeks, 61.9% of CagriSema-treated participants were receiving the highest dose. CagriSema is an investigational, once-weekly subcutaneous fixed-dose combination of the long-acting amylin analogue cagrilintide (2.4 mg) and the glucagon like peptide-1 receptor agonist semaglutide (2.4 mg).

The findings

Over the 68-week study period, participants treated with CagriSema experienced an average weight reduction of 15.7%, compared to 3.1% with placebo, when assessing only those who adhered to treatment. When applying a broader treatment policy analysis, weight loss was 13.7% with CagriSema vs 3.4% with placebo.

The trial also met its co-primary endpoint of weight loss of at least 5% at 68 weeks, with 89.7% of participants on CagriSema reaching the goal vs 30.3% in the placebo group.

The REDEFINE 2 safety data indicated that CagriSema was well tolerated. The most common adverse events were gastrointestinal-related, were primarily mild to moderate, and diminished over time, consistent with the known safety profile of GLP-1 receptor agonists.

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