WASHINGTON (dpa-AFX) - Novo Nordisk (NVO) announced positive primary results from the Phase 3 REDEFINE 9 trial evaluating CagriSema, an investigational treatment for adults with overweight or obesity. CagriSema combines the long-acting amylin analogue cagrilintide with the GLP-1 receptor agonist semaglutide in a fixed-dose formulation.
The REDEFINE 9 study is the first Phase 3 weight-management trial to assess CagriSema at doses below the maximum 2.4 mg/2.4 mg level used in the broader REDEFINE clinical program.
Results showed that patients treated with CagriSema 1.7 mg/1.7 mg achieved an estimated average weight loss of 20.7% after 68 weeks, while those receiving the 1.0 mg/1.0 mg dose achieved a 21.0% average weight reduction. In comparison, patients in the placebo group recorded an average weight loss of 2.0%.
The findings were based on an analysis assuming all participants remained on treatment throughout the 68-week study period.
At both doses, a significantly higher proportion of adults achieved body weight reductions of at least 5%, 10%, 15% and 20% compared with placebo. Both CagriSema 1.7 mg / 1.7 mg and 1.0 mg / 1.0 mg also produced significantly greater reductions in abdominal fat, as measured by waist circumference, a confirmatory secondary endpoint.
Based on the treatment regimen estimand, estimated average weight loss at week 68 was 19.4% and 18.6% with CagriSema 1.7 mg /1.7 mg and 1.0 mg / 1.0 mg, respectively, compared with 4.6% with placebo, and 92.8% and 87.7%, respectively, achieved at least 5% body weight reduction, compared with 41.1% with placebo.
NVO closed Friday's regular trading at $41.63 up $0.98 or 2.41%.
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