Weight management · Phase 3
REDEFINE 2: combination treatment with diabetes
NCT05394519 ↗ · Combined treatment
What was tested?
Cagrilintide plus semaglutide versus placebo, with lifestyle intervention, in adults with type 2 diabetes and excess body weight. ↗
Registered primary question: Percentage weight change and the proportion losing at least 5% of baseline weight at week 68. ↗
What the reviewed report found
Journal year 2025 · Article summary reviewed 2026-09-15
The treatment-policy analysis reported mean weight changes of −13.7% with cagrilintide-semaglutide versus −3.4% with placebo. Gastrointestinal adverse events occurred in 72.5% and 34.4%, respectively.↗
Keep in context: These are combination-treatment results. The paper identifies a treatment-policy analysis; its estimates should not be mixed with a different estimand without checking the analysis definition. ↗↗
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 1,200 · reported actual
- Registry status
- Completed
- Allocation and masking
- Randomized · Quadruple
- Design
- Parallel
- Eligible ages
- 18 Years; maximum not specified
- Registry results
- Not posted in this snapshot
Registry source ↗ · Updated 2026-01-28; 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 2: combination treatment with diabetes
- Design in the report
- A blinded randomized placebo-controlled phase 3a trial assessed weight endpoints at 68 weeks under NCT05394519.↗
- Participants in the report
- The study randomized 1,206 adults with type 2 diabetes and overweight or obesity.↗
- Limitations
- This comparison evaluates the combination against placebo, not either component alone. Weight and glycemic outcomes do not establish prevention of long-term complications.↗
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 Type 2 Diabetes and Excess Body Weight Lose Weight ↗
Protocol identifier: NN9838-4609. Sponsor: Novo Nordisk A/S.
Retrieved 2026-09-20; SHA-256 89c12b78bce80ab393db40359d5b74b712703eb775ac5269a4f33736957f885a.
PMID 40544432
Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. ↗
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 40544432. SHA-256 adc8edd8b150d99a3641ddbc74c59db6916cf35d9d6246838aaff2cc195ae1cb.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 d23f7edea7a684abf0d324dda051b8fb83ea814a8f06313783512df8e5c61219.