LivingGLP1
Study S001912

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

Registration

Registration
NCT05394519
Acronym
REDEFINE 2
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
1200
Start
2023-02-01
Primary completion
2025-01-28
Lead sponsor
Novo Nordisk A/S
Conditions
Overweight; Obesity; Type 2 Diabetes Mellitus
Interventions
DRUG:Cagrilintide; DRUG:Semaglutide; DRUG:Placebo cagrilintide; DRUG:Placebo semaglutide
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1267-4287; EUDRACT_NUMBER:2021-005121-24; REGISTRY:jRCT2031220671

Registered primary outcomes

  • Relative change in body weight [From baseline (week 0) to end of treatment (week 68)]
  • Achievement of greater than or equal to (≥) 5% weight reduction [From baseline (week 0) to end of treatment (week 68)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0007868Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.
Davies MJ, The New England journal of medicine
2025Randomized trialPMID 40544432DOIcites ClinicalTrials.gov:NCT05394519; registry reference DERIVED:40544432