Novo Nordisk revealed the major findings from REDEFINE 2, a phase 3 trial that is part of the global REDEFINE program. The efficacy and safety of once-weekly subcutaneous CagriSema, a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, was examined in the 68-week REDEFINE 2 trial in comparison to a placebo. The study comprised 1,206 randomly selected participants with type 2 diabetes, obesity, or overweight, with a mean baseline body weight of 102 kg.
CagriSema showed a statistically significant and superior weight loss at week 68 compared to placebo, meeting the trial’s primary aim.
A flexible protocol underpinned the REDEFINE 2 trial, enabling patients to adjust their dosage at any time during the study. The maximal dose was used by 61.9% of CagriSema-treated patients after 68 weeks.
After 68 weeks, those treated with CagriSema lost more weight (15.7%) than those given with a placebo (3.1%), assuming everyone followed their prescribed course of action. A co-primary objective was weight loss of 5% or more after 68 weeks, which was attained by 89.7% of CagriSema patients and 30.3% of placebo-treated individuals.
Those treated with CagriSema lost more weight (13.7%) than those treated with a placebo (3.4%), according to the treatment policy estimand.
CagriSema seemed to have a well-tolerated and safe profile during the experiment. Consistent with the GLP-1 receptor agonist class, the majority of CagriSema’s adverse events were mild to moderate and gradually subsided, with gastrointestinal side effects being the most frequent.
The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes,
We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.
Martin Holst Lange
In the first quarter of 2026, Novo Nordisk anticipates submitting a request for CagriSema’s initial regulatory approval. In 2025, a scientific conference will feature the comprehensive findings from REDEFINE 1 and REDEFINE 2.
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CagriSema
Novo Nordisk is investigating once-weekly subcutaneous CagriSema as a therapy for individuals with type 2 diabetes (REIMAGINE study) and overweight or obesity (REDEFINE program). CagriSema is a fixed-dose combination of semaglutide 2.4 mg and cagrilintide 2.4 mg, a long-acting amylin analogue. By decreasing appetite and enhancing feelings of fullness, the two molecules help people eat less and consume fewer calories, which leads to weight loss.
Source: Novo Nordisk
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