A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

Phase 3 Completed 331 enrolled Novo Nordisk A/S

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

Timeline

Start: 2023-04-03
Primary completion: 2025-01-17
Completion: 2025-03-07

Outcome

Met primary endpoint

paper change in bodyweight from baseline to week 68 was -18·4% (SE 0·7) in the cagrilintide-semaglutide group versus -11·9% (0·7) in the semaglutide group PMID 42009015 ↗

paper estimated treatment difference [ETD] -6·5 percentage points [95% CI -8·4 to -4·6]; p<0·0001 PMID 42009015 ↗

Publications

Yamauchi T, Becker NP, Hagemann CA, Huang KC, Kiyosue A, Lim S, Onishi Y, Kosuvaripalli A, Takano T, Ishigaki Y; REDEFINE 5 study group. Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2026 Jun;14(6):450-462. doi: 10.1016/S2213-8587(25)00402-4. Epub 2026 Apr 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cagrilintide	Protein / enzyme biologic	2.4 mg	Subcutaneous
Subject	Semaglutide	Peptide	2.4 mg	Subcutaneous