A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Phase 3 Completed 1200 enrolled Novo Nordisk A/S

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Timeline

Start: 2023-02-01
Primary completion: 2025-01-28
Completion: 2025-02-03

Outcome

Met primary endpoint

paper weight from baseline to week 68 was -13.7% in the cagrilintide-semaglutide group and -3.4% in the placebo group PMID 40544432 ↗

paper estimated difference, -10.4 percentage points; 95% confidence interval, -11.2 to -9.5; P<0.001 PMID 40544432 ↗

Publications

Davies MJ, Bajaj HS, Broholm C, Eliasen A, Garvey WT, le Roux CW, Lingvay I, Lyndgaard CB, Rosenstock J, Pedersen SD; REDEFINE 2 Study Group. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025 Aug 14;393(7):648-659. doi: 10.1056/NEJMoa2502082. Epub 2025 Jun 22.

Drugs

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