The Danish laboratory published the top-line results of REDEFINE 1, a Phase III trial measuring efficacy and safety at 68 weeks on subcutaneous administration of CagriSema (CagriSema).of CagriSema (a fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared with the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 3,417 randomized overweight or obese subjects with one or more comorbidities and a mean initial weight of 106.9 kg.
The trial met its primary objective by demonstrating statistically significant and superior weight loss at week 68 with CagriSema versus placebo. Those treated with CagriSema achieved a 22.7% greater weight loss after 68 weeks, compared with an 11.8% reduction with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone. On average, buyers surveyed by Jefferies were expecting an absolute weight loss of 25-27%.
The Danish index, OMX Copenhagen 20, collapsed by 15%, with Novo Nordisk by far the leading weighting.