Evidence status · reviewed 1 August 2026
One dated view of the CagriSema Phase 3 program — REDEFINE in obesity and REIMAGINE in type 2 diabetes — separating peer-reviewed results from sponsor topline readouts, including where a head-to-head endpoint was not met. Evidence state comes before headline magnitude.
CagriSema remains investigational and is not approved by any regulator; a US chronic-weight-management application is under review. This tracker is research context, not clinical or personal-use guidance.
The statuses below describe the source available for each result, not an approval status or a judgment about clinical use.
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).
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).
Type 2 diabetes on metformin ± SGLT2 inhibitor · Phase 3 · 68 weeks
Published in Lancet Diabetes & Endocrinology, CagriSema reduced A1C by 1.91 percentage points and body weight by 14.2% at week 68 (efficacy estimand) versus 1.76 points and 10.2% for semaglutide 2.4 mg, from a baseline A1C of 8.2%; superiority was established versus the individual components (NCT06065540).
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).
Obesity, open-label head-to-head vs tirzepatide 15 mg · Phase 3 · 84 weeks
In the sponsor topline, CagriSema produced 23.0% weight loss versus 25.5% with tirzepatide 15 mg at 84 weeks (efficacy estimand); the trial did not meet its primary endpoint of demonstrating non-inferiority to tirzepatide (n=809, NCT06131437).
Obesity with established cardiovascular disease · Phase 3 · event-driven
The cardiovascular-outcomes trial is active with an estimated completion in 2027. Detailed results were not identified as published at this tracker’s review (NCT05669755).
How to read this tracker
A full report has passed journal review and exposes methods and analyses for scrutiny.
A primary-source company release is available, but the complete paper may not yet be published.
The registry establishes design and status; it does not substitute for a results publication.
See where CagriSema sits in the wider incretin pipeline, then check the sister approval tracker on Remy Peptides.