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Randomized controlled trial

REDEFINE 1: CagriSema for obesity without diabetes

CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg, once weekly) reduced weight by 20.4% at 68 weeks, compared with 3.0% on placebo; the estimated difference was −17.3 percentage points (95% CI, −18.1 to −16.6; p < 0.001).

Garvey WT et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. New England Journal of Medicine, 2025. DOI: 10.1056/NEJMoa2502081

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Key facts

Drugs
CagriSema and semaglutide
Design
Randomized controlled trial
Participants
3,417
Duration
68 weeks
Funding
Novo Nordisk
Registry
NCT05567796
Population
3,417 adults with obesity (or overweight with at least one comorbidity), without diabetes, assigned to CagriSema, semaglutide alone, cagrilintide alone or placebo.
Primary outcome
Percentage change in body weight and proportion losing at least 5% at 68 weeks, CagriSema versus placebo.

What it found

Mean weight loss, % of starting weight · 68 weeks
  • CagriSema 2.4/2.4 mg weekly−20.4%
  • Placebo−3.0%

Difference: −17.3 points vs placebo (95% CI, −18.1 to −16.6).

Figures from the paperSee the results in a chart

CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg, once weekly) reduced weight by 20.4% at 68 weeks, compared with 3.0% on placebo; the estimated difference was −17.3 percentage points (95% CI, −18.1 to −16.6; p < 0.001). According to the sponsor’s press release, the semaglutide-alone and cagrilintide-alone groups lost 14.9% and 11.5% with the same estimand; those figures are not in the paper’s abstract. The most common adverse effects were digestive.

Limitations

Funded by Novo Nordisk. The confidence intervals for the comparisons with semaglutide alone and cagrilintide alone are not in the published abstract. Flexible dosing was allowed, which complicates interpretation. The product was not approved in any country as of the review date.

What it means for you

REDEFINE 1 showed that CagriSema, the weekly combination of cagrilintide and semaglutide, reduced weight by an average of 20.4% over 68 weeks in people without diabetes. It is an investigational combination. These data help show where research is heading; they are not a basis for choosing a treatment today.

Further reading

Related trials

  • CagriSema68 weeks

    REDEFINE 2

    In people with type 2 diabetes, CagriSema reduced weight by 13.7% at 68 weeks, compared with 3.4% on placebo.

  • semaglutide64 weeks

    OASIS 4

    Weight changed by −13.6% with oral semaglutide 25 mg and −2.2% with placebo at 64 weeks.

  • semaglutide72 weeks

    STEP UP

    At 72 weeks, weight changed by −18.7% with semaglutide 7.2 mg, −15.6% with 2.4 mg and −3.9% with placebo.

  • tirzepatide and semaglutide72 weeks

    SURMOUNT-5

    At 72 weeks, weight fell by 20.2% with tirzepatide and 13.7% with semaglutide.

Sources

The original paper and the records consulted for this summary, with the date they were accessed.

  1. New England Journal of Medicine.Garvey WT, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393(7):635-647.accessed .
  2. National Library of Medicine (PubMed).PubMed record PMID 40544433 (abstract).accessed .
  3. Novo Nordisk A/S (GlobeNewswire).Novo Nordisk press release: CagriSema demonstrates superior weight loss in adults with obesity or overweight in the REDEFINE 1 trial (20 December 2024).accessed .