REDEFINE 1 is Novo Nordisk's Phase 3 obesity trial for CagriSema, the once-weekly fixed-dose combination of cagrilintide 2.4 mg (amylin analog) and semaglutide 2.4 mg (GLP-1 agonist). The trial reported a 22.7% mean weight reduction at week 68 — short of the 25% internal target that drove a Novo stock pullback in early 2025 — but solidly within the clinical-meaningfulness range and ahead of Wegovy 2.4 mg monotherapy.
The May 12, 2026 ECO 2026 presentations expanded the picture: the prespecified body-composition substudy showed a 35.7% relative reduction in fat mass and 14.4% in lean tissue at week 68 (favorable 2.5:1 ratio versus 1.5-2:1 for GLP-1 monotherapy); the BMI + waist-to-height ratio target-achievement analysis showed 50.7% of CagriSema-treated participants reached BMI <30 vs 10.2% on placebo, with cardiometabolic normalization rates higher in target-achievers. A REDEFINE 1 predicted atherosclerotic CVD risk analysis was scheduled for May 14 ECO presentation.
Stories here cover the body-composition, BMI-target, and cardiovascular sub-analyses, plus the NDA filing trajectory. See #cagrisema, #cagrilintide, and #novo-nordisk.
Novo Nordisk's CagriSema REDEFINE 1 treatment-target analysis presented as an oral presentation at ECO 2026 on May 12 reported that the cagrilintide + semaglutide combination drove a higher percentage of participants to clinically meaningful BMI and waist-to-height ratio (WHtR) targets than any monotherapy or placebo arm. 50.7% of CagriSema-treated participants reached BMI <30 at week 68 vs 10.2% on placebo, and participants reaching BMI <27 plus WHtR <0.53 showed normalization of cardiometabolic parameters at higher rates than non-achievers. A companion REDEFINE 1 cardiovascular risk analysis scheduled for May 14 ECO presentation tracks predicted atherosclerotic CVD risk reduction. The data complements the May 12 body-composition substudy (35.7% fat-mass loss vs 14.4% lean tissue loss).
A prespecified body-composition substudy of REDEFINE 1 presented at ECO 2026 reported that 252 participants on CagriSema 2.4 mg/2.4 mg (semaglutide + cagrilintide) achieved a 35.7% relative reduction in fat mass and a 14.4% reduction in lean soft-tissue mass at week 68 — compared with 5.7% and 4.3% on placebo. The headline 22.7% mean weight reduction in REDEFINE 1 (NEJM publication June 2025) thus broke down with a fat-mass-to-lean-tissue ratio of roughly 2.5:1, a more favorable body-composition profile than the typical 1.5-2:1 ratio reported for GLP-1 monotherapy. The data builds the case for combination amylin-GLP-1 therapy as preferentially fat-selective.
Novo Nordisk announced April 28 that it will present 52 abstracts at the European Congress on Obesity (ECO 2026, Istanbul, May 12–15), including new data from the REDEFINE 1 trial of CagriSema (cagrilintide 2.4 mg/semaglutide 2.4 mg): body composition and muscle strength, achievement of BMI/waist-to-height ratio targets, and cardiovascular risk reduction. Additional presentations will cover higher-dose Wegovy (semaglutide 7.2 mg), the Wegovy pill (oral semaglutide 25 mg) from OASIS 4 and ORION trials, and obesity treatment outcomes in women. The disclosure sets up a significant amylin/GLP-1 combination data event exactly as Zealand and Roche's amylin-only petrelintide moves into Phase 3.