Study S001612

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

ClinicalTrials.gov record

Registration

Registration: NCT06065540
Acronym: REIMAGINE 2
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 2734
Start: 2023-09-27
Primary completion: 2025-11-19
Lead sponsor: Novo Nordisk A/S
Conditions: 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:U1111-1283-0427; EUDRACT_NUMBER:2022-502678-18

Registered primary outcomes

CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c) [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.

Record	Title	Year	Design	Identifiers	Link basis
R0004267	Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. Buse JB, The lancet. Diabetes & endocrinology	2026	Randomized trial	PMID 42251859 DOI	cites ClinicalTrials.gov:NCT06065540; registry reference DERIVED:42251859