Novo Nordisk (NYSE: NVO) announced topline results from two phase 3 clinical trials of CagriSema, an investigational combination of cagrilintide and semaglutide being developed for weight management and type 2 diabetes. The results were presented at the company's Capital Markets Day investor briefing.

In the REIMAGINE 5 trial, CagriSema at a dose of 1.0 mg/1.0 mg achieved an estimated average weight loss of 12.4% in adults with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitors, or both, compared with 9.1% for tirzepatide 5 mg, meeting the superiority endpoint. CagriSema also demonstrated non-inferior reduction in HbA1c at 1.71%, versus 1.67% for tirzepatide, over 60 weeks.

In the REDEFINE 9 trial, CagriSema 1.0 mg/1.0 mg produced a 21.0% reduction in body weight compared with 2.0% for placebo in adults with overweight or obesity as an adjunct to diet and exercise, meeting the primary superiority endpoint at week 68. CagriSema also showed greater improvements than placebo across prespecified supportive endpoints including systolic blood pressure, waist-to-height ratio, and fasting lipid profile.

Martin Holst Lange, executive vice president of Research & Development and chief scientific officer at Novo Nordisk, said the results "demonstrate the strong potency of the combination of semaglutide and cagrilintide" and noted that "these findings strengthen our confidence in its potential."

Novo Nordisk also presented data on painful diabetic neuropathy in type 2 diabetes for the first time during the Capital Markets Day event, describing the results as promising. Additional details are expected to be disclosed at a later date.

CagriSema remains an investigational product and has not yet received regulatory approval.