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NCT05394519 (CagriSema in Overweight Obesity Type 2 Diabetes Mellitus): BVCT ex-ante prediction vs. reported outcome

On 31 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 10 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (superior to semaglutide yet inferior to tirzepatide).

Clinical Trial

NCTID
NCT05394519
Acronym
REDEFINE 2
Drug Name
CagriSema
Drug MoA
combo amylin analog + GLP1R agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Overweight Obesity Type 2 Diabetes Mellitus
Human Patients
1200
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1518

Prospective Prediction
Prediction Index
1518
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in HbA1c and weight reduction at most numerically superior to semaglutide for obese T2DM patients)
Technical Prediction
SUCCESS (statistically significant clinical benefit in HbA1c and weight reduction compared with placebo yet featuring negative morbidity-response relationship and negative age-response relationship for obese T2DM patients)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
38 days in advance
Readout Data Interpretation
CagriSema achieved 10.3% placebo-adjusted weight loss at week 68; which is superior to semaglutide that achieved 6.2% placebo-adjusted weight loss at week 68 (DOI-10.1016/S0140-6736(21)00213-0); yet inferior to tirzepatide achieved 12.2% placebo-adjusted weight loss at week 68 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (superior to semaglutide yet inferior to tirzepatide)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
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
Phase
Phase 3
Status
Completed
Enrollment
1200
Lead sponsor
Novo Nordisk A/S
Conditions
Overweight; Obesity; Type 2 Diabetes Mellitus
Interventions
DRUG: Cagrilintide; DRUG: Semaglutide; DRUG: Placebo cagrilintide; DRUG: Placebo semaglutide
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-02-01
Primary completion
2025-01-28
Completion
2025-02-03
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))

NCT05394519 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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