CagriSema is a fixed-dose, once-weekly injection that pairs cagrilintide 2.4 mg, a long-acting amylin analogue, with semaglutide 2.4 mg, the GLP-1 receptor agonist already sold as Wegovy. Novo Nordisk submitted a New Drug Application to the U.S. FDA on 18 December 2025; company guidance points to a regulatory decision in the fourth quarter of 2026. That filing, and the countdown to a first-in-class approval, is what is driving the current wave of search and forum interest.
In the phase 3 REDEFINE 1 trial in adults with obesity or overweight, CagriSema produced average body-weight loss of 20.4% versus 3.0% for placebo at 68 weeks under the treatment-policy analysis, rising to 22.7% when assuming everyone stayed on treatment. About 54% of participants dropped below the obesity BMI threshold, compared with roughly 11% on placebo.
The headline number is large but landed below expectations. Novo Nordisk had signalled hopes of around 25% weight loss, and one factor was that most trial participants did not escalate to, or stay at, the top dose — a reminder that real-world results depend heavily on tolerability and titration.
Gastrointestinal side effects dominated the safety profile: 79.6% of the CagriSema group reported GI events versus 39.9% on placebo, including nausea (55% vs 12.6%), constipation (30.7% vs 11.6%) and vomiting (26.1% vs 4.1%). Discontinuation for adverse events stayed low at 5.9% versus 3.5%.
The honest trade-off: CagriSema adds amylin agonism on top of the best-selling GLP-1, and the combination clears 20%-plus weight loss — but it did not decisively separate from high-dose tirzepatide-class results, and the GI burden is real. Nothing is approved yet, and grey-market 'cagrilintide' or blended products carry no assurance of dose or purity.