Novo Nordisk Reports CagriSema Beat Tirzepatide on Weight Loss in Phase 3 REIMAGINE 5 Trial

Novo Nordisk said on September 21, 2026, at its Capital Markets Day investor briefing, that it had topline results from two additional Phase 3 trials of CagriSema, its investigational once-weekly combination of the amylin analogue cagrilintide and the GLP-1 receptor agonist semaglutide. One trial, REIMAGINE 5, compared CagriSema head-to-head against tirzepatide in people with type 2 diabetes. The other, REDEFINE 9, compared CagriSema against placebo in people with overweight or obesity.

REIMAGINE 5 (ClinicalTrials.gov identifier NCT06534411) enrolled 1,023 adults with type 2 diabetes inadequately controlled on metformin, an SGLT2 inhibitor, or both, and randomized them to once-weekly CagriSema 1.0 mg/1.0 mg or once-weekly tirzepatide 5 mg. Novo Nordisk reported that CagriSema was superior to tirzepatide on its primary weight-loss endpoint, producing an estimated average weight loss of 12.4% at week 60 compared with 9.1% for tirzepatide. The company said CagriSema also showed non-inferior HbA1c reduction, at 1.71 percentage points versus 1.67 percentage points for tirzepatide.

REDEFINE 9 (ClinicalTrials.gov identifier NCT06388187) enrolled 300 adults with overweight or obesity and tested two CagriSema doses, 1.0 mg/1.0 mg and 1.7 mg/1.7 mg, against placebo, as an adjunct to a reduced-calorie diet and increased physical activity. The trial's primary endpoints were relative change in body weight and the proportion of participants achieving at least 5% body-weight reduction from baseline to week 68. Novo Nordisk reported that the CagriSema 1.0 mg/1.0 mg dose met the superiority bar on the weight-loss endpoint, with an estimated average weight loss of 21.0% at week 68 compared with 2.0% for placebo. The company's release did not disclose a corresponding weight-loss figure for the higher 1.7 mg/1.7 mg dose, nor the specific proportion of participants in either dose group who reached the 5% weight-loss threshold. The weight-loss figures in both trials were based on Novo Nordisk's efficacy estimand, which estimates the treatment effect assuming continued adherence to trial medication.

On safety, Novo Nordisk's announcement stated only that "CagriSema was well tolerated overall, with a safety profile consistent with previous studies" in both trials, without reporting specific adverse-event rates, discontinuation rates, or gastrointestinal side-effect frequencies for either trial.

Martin Holst Lange, Novo Nordisk's executive vice president for research and development and chief scientific officer, said in the announcement: "The results from CagriSema are very encouraging, demonstrating the strong potency of the combination of semaglutide and cagrilintide."

The figures released on September 21 are topline results disclosed in a corporate announcement timed to Novo Nordisk's Capital Markets Day; they have not been peer-reviewed or presented in full at a scientific meeting. CagriSema remains investigational and is not approved by the FDA, the European Medicines Agency, or any other regulator. Novo Nordisk filed a New Drug Application for CagriSema for chronic weight management with the FDA in December 2025, and the company's September 21 announcement said an FDA decision on that application is expected in the fourth quarter of 2026. The trial figures describe study outcomes and should not be read as a claim about any authorized treatment.