NCT05567796 study context · version 1

Weight management · Phase 3

REDEFINE 1: combination treatment without diabetes

What was tested?

Cagrilintide plus semaglutide, either component alone, or placebo alongside lifestyle intervention. ↗

Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 68, comparing the combination with placebo. ↗

What the reviewed report found

Journal year 2025 · Article summary reviewed 2026-09-15

The treatment-policy analysis reported mean weight changes of −20.4% with cagrilintide-semaglutide versus −3.0% with placebo. Gastrointestinal adverse events occurred in 79.6% and 39.9%, respectively.^↗

Keep in context: The registry still lists estimated enrollment of 3,400; the report describes 3,417 randomized participants. Its headline combination-versus-placebo result is not a cagrilintide-alone result. ↗↗

Participants, design, limitations and sources

Registry snapshot

Registry enrollment: 3,400 · estimated
Registry status: Active not recruiting
Allocation and masking: Randomized · Quadruple
Design: Parallel
Eligible ages: Minimum not specified; maximum not specified
Registry results: Not posted in this snapshot

Registry source ↗ · Updated 2026-08-31; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.

REDEFINE 1: combination treatment without diabetes

Design in the report: A blinded randomized phase 3a trial compared combination treatment, either component alone and placebo over 68 weeks under NCT05567796.^↗
Participants in the report: The trial randomized 3,417 adults with overweight or obesity without diabetes across four groups.^↗
Limitations: These estimates concern the combination and cannot be attributed to cagrilintide alone. The abstract does not give the component-alone outcome estimates needed to assess each component’s contribution.^↗

This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →

How the study identity and sources were checked

Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.

Registry

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight ↗
Protocol identifier: NN9838-4608. Sponsor: Novo Nordisk A/S.
Retrieved 2026-09-20; SHA-256 7fe4f6e62177c7e1693e7257b9987ca0098b420301130597539aa2e5944b34d3.

PMID 40544433

Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. ↗

Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.

Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 40544433. SHA-256 adc8edd8b150d99a3641ddbc74c59db6916cf35d9d6246838aaff2cc195ae1cb.

Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 11e3e0de9860bd4ec6e03db65d1b6e40b2731f5bc7818904b72a8e04b3c0d77d.