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NCT06221969 (CagriSema in Type 2 Diabetes): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 4 Aug 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically partially insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06221969
Acronym
REIMAGINE 4
Drug Name
CagriSema
Drug MoA
combo peptide amylin analog + GLP1R agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Type 2 Diabetes
Human Patients
1024
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1516

Prospective Prediction
Prediction Index
1516
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to tirzepatide in both HbA1c and weight reduction)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit in HbA1c and weight reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
863 days in advance
Readout Data Interpretation
CagriSema achieved 15.2% weight loss, which is numerically inferior to 15.8% achieved by tirzepatide in the same trial; CagriSema achieved 1.9% HbA1c reduction, which is inferior to 2.2% HbA1c reduction achieved by tirzepatide in the same trial.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Phase
Phase 3
Status
Completed
Enrollment
1024
Lead sponsor
Novo Nordisk A/S
Conditions
Type 2 Diabetes
Interventions
DRUG: Cagrilintide; DRUG: Semaglutide; DRUG: Tirzepatide
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2024-01-16
Primary completion
2026-03-04
Completion
2026-04-06
Primary outcomes
  • Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to end of treatment (week 68))
  • Relative change in body weight (From baseline (week 0) to end of treatment (week 68))

NCT06221969 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials