Study S001154

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

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT05567796
Acronym: REDEFINE 1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 3400
Start: 2022-11-01
Primary completion: 2024-10-30
Lead sponsor: Novo Nordisk A/S
Conditions: Obesity
Interventions: DRUG:Cagrilintide; DRUG:Semaglutide; DRUG:Placebo cagrilintide; DRUG:Placebo semaglutide
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:Universal Trial Number (UTN); EUDRACT_NUMBER:2020-005435-75

Registered primary outcomes

CagriSema versus placebo: Relative change in body weight [From baseline (week 0) to end of treatment (week 68)]
CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction [From baseline (week 0) to end of treatment (week 68)]

Linked records (3)

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.

Record	Title	Year	Design	Identifiers	Link basis
R0006424	CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1. Verma S, Hypertension (Dallas, Tex. : 1979)	2026	Randomized trial	PMID 41328546 DOI	cites ClinicalTrials.gov:NCT05567796; registry reference DERIVED:41328546
R0037289	1695-P: Effect of CagriSema on Eating Control and Behavior: REDEFINE 1 Michelle Dalton, Diabetes	2026	Randomized trial	DOI	cites ClinicalTrials.gov:NCT05567796
R0007826	Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. Garvey WT, The New England journal of medicine	2025	Randomized trial	PMID 40544433 DOI	cites ClinicalTrials.gov:NCT05567796; registry reference DERIVED:40544433