Claimed effect · CagriSema

Does CagriSema help with body weight?

B
Grade B — probable, not settled1 phase 3 RCT topline (REIMAGINE 5, 60 wk) · effect size: moderate
Short answerProbable, not settled. Human data exist (1 phase 3 RCT topline (REIMAGINE 5, 60 wk)) and mostly agree, showing a moderate effect — but too few, too small, or not yet peer-reviewed for a firm answer. Novo Nordisk press release, 21 September 2026: in adults with type 2 diabetes not controlled on metformin, an SGLT2 inhibitor or both, CagriSema 1.0 mg/1.0 mg produced 12.4% weight loss at 60 weeks against 9.1% on tirzepatide 5 mg, with HbA1c reductions of 1.71 and 1.67 points (non-inferior). Both arms were low doses: tirzepatide's lowest maintenance dose, and less than half the 2.4 mg/2.4 mg of CagriSema used in REDEFINE 1. Efficacy estimand; enrolment not stated; not peer-reviewed, so B. The same release reports 21.0% against 2.0% on placebo at 68 weeks for the 1.0 mg/1.0 mg dose in obesity (REDEFINE 9).

What the studies show

Novo Nordisk press release, 21 September 2026: in adults with type 2 diabetes not controlled on metformin, an SGLT2 inhibitor or both, CagriSema 1.0 mg/1.0 mg produced 12.4% weight loss at 60 weeks against 9.1% on tirzepatide 5 mg, with HbA1c reductions of 1.71 and 1.67 points (non-inferior). Both arms were low doses: tirzepatide's lowest maintenance dose, and less than half the 2.4 mg/2.4 mg of CagriSema used in REDEFINE 1. Efficacy estimand; enrolment not stated; not peer-reviewed, so B. The same release reports 21.0% against 2.0% on placebo at 68 weeks for the 1.0 mg/1.0 mg dose in obesity (REDEFINE 9).

Human trials exist and mostly agree, but there are too few of them, they are too small, or one big one is still reading out. Expect the grade to move.

  1. 1
    Novo Nordisk. CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5 trial (with REDEFINE 9 topline).Press release, 21 Sep 2026REIMAGINE 5: 60 weeks, type 2 diabetes, vs tirzepatide 5 mg. REDEFINE 9: 68 weeks, obesity, vs placebo. Topline, efficacy estimand; not peer-reviewed. States the US filing of December 2025 and a decision expected in Q4 2026.

In context

CagriSema is a once-weekly co-injection of cagrilintide, an amylin analogue, with semaglutide 2.4 mg. In REDEFINE 1, a 3,417-person phase 3 trial published in 2025, it produced 20.4% average weight loss at 68 weeks against 3.0% on placebo; in people with type 2 diabetes the figure was 13.7%. Both trials are peer-reviewed. It is not yet approved anywhere, and anything sold under the name is not the trial product.

CagriSema is investigational (filed). Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is CagriSema proven to help with body weight?
Not yet settled. 1 phase 3 RCT topline (REIMAGINE 5, 60 wk) — LYO grades it B, meaning probable but liable to change as trials read out.
What studies are behind the grade?
Novo Nordisk press release, 21 September 2026: in adults with type 2 diabetes not controlled on metformin, an SGLT2 inhibitor or both, CagriSema 1.0 mg/1.0 mg produced 12.4% weight loss at 60 weeks against 9.1% on tirzepatide 5 mg, with HbA1c reductions of 1.71 and 1.67 points (non-inferior). Both arms were low doses: tirzepatide's lowest maintenance dose, and less than half the 2.4 mg/2.4 mg of CagriSema used in REDEFINE 1. Efficacy estimand; enrolment not stated; not peer-reviewed, so B. The same release reports 21.0% against 2.0% on placebo at 68 weeks for the 1.0 mg/1.0 mg dose in obesity (REDEFINE 9).
Is CagriSema approved for this?
No. CagriSema is investigational (filed); it is not an approved medicine for any indication in the jurisdictions LYO covers.

Other outcomes for CagriSema

Written and maintained by LYO Research — how pages are written and checked. Reviewed 7 October 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →