CagriSema Phase 3 evidence tracker

REDEFINE 1

Overweight or obesity, without type 2 diabetes · Phase 3 · 68 weeks

Published in NEJM, estimated mean body-weight change at week 68 was −20.4% with cagrilintide-semaglutide versus −3.0% with placebo on the treatment-policy estimand; with full adherence (efficacy estimand) weight loss was 22.7% versus 2.3% (n=3,417, NCT05567796).

Sponsor conference analysis (post hoc), 20 October 2026. Novo Nordisk reported two post hoc analyses of REDEFINE 1 in women at The Menopause Society 2026 Annual Meeting. Among all 2,309 women in the trial, average weight loss at week 68 was 25.0% with CagriSema versus 3.0% with placebo, if all participants stayed on treatment (efficacy estimand). In 1,902 women grouped by menopausal status, average weight loss was 26.7% in premenopausal, 24.8% in perimenopausal and 23.1% in postmenopausal women, versus 1.7% to 2.6% with placebo. Menopausal status was assigned after the trial from age, medical history and symptoms, and women using hormone therapy were analysed separately. These are company-reported poster results that have not been peer reviewed, and Novo described them as hypothesis generating.

REDEFINE 2

Overweight or obesity and type 2 diabetes · Phase 3 · 68 weeks

Published in NEJM, body-weight change at week 68 was −13.7% versus −3.4% with placebo (treatment-policy estimand), and 73.5% of the CagriSema group reached A1C ≤6.5% versus 15.9% with placebo; efficacy-estimand weight loss was −15.7% versus −3.1% (n=1,206, NCT05394519).

REIMAGINE 1

Type 2 diabetes on diet and exercise · Phase 3 · 40 weeks

Published in Lancet Diabetes & Endocrinology, CagriSema 2.4/2.4 mg changed A1C by −1.8 percentage points and body weight by −13.8% at week 40 versus −0.1 points and −1.4% with placebo (efficacy estimand; n=189, NCT06323174).

REIMAGINE 2

Type 2 diabetes on metformin ± SGLT2 inhibitor · Phase 3 · 68 weeks

Published in Lancet Diabetes & Endocrinology, CagriSema reduced A1C by 1.91 percentage points versus 1.75 points with semaglutide 2.4 mg at week 68 (efficacy estimand), from a baseline A1C of 8.2%; superiority was established versus the individual components. The weight figures (−14.2% versus −10.2%) come from Novo’s topline; the paper’s abstract reports A1C only (NCT06065540).

REIMAGINE 3

Type 2 diabetes as add-on to basal insulin · Phase 3 · 40 weeks

Published in The Lancet, mean A1C fell 2.33 percentage points with CagriSema versus 0.66 with placebo at week 40 (efficacy estimand; treatment difference −1.68 points), with body-weight reductions of 10–12% (n=274, NCT06323161).