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NCT05567796 (CagriSema in Obesity): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 20 Dec 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (superior to semaglutide).

Clinical Trial

NCTID
NCT05567796
Acronym
REDEFINE 1
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
Obesity
Human Patients
3400
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1517

Prospective Prediction
Prediction Index
1517
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit with superior-to-semaglutide-and-cagrilintide efficacy weight reduction)
Technical Prediction
SUCCESS (statistically significant clinical benefit in weight reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
271 days in advance
Readout Data Interpretation
CagriSema achieved 20.4% placebo-adjusted weight loss at week 68; which is superior to semaglutide that achieved 13.8% placebo-adjusted weight loss at week 68 and cagrilintide that achieved 9.5% placebo-adjusted weight loss at week 68 as the active control arm
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (superior to semaglutide)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
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
Phase
Phase 3
Status
Active not recruiting
Enrollment
3400
Lead sponsor
Novo Nordisk A/S
Conditions
Obesity
Interventions
DRUG: Cagrilintide; DRUG: Semaglutide; DRUG: Placebo cagrilintide; DRUG: Placebo semaglutide
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-11-01
Primary completion
2024-10-30
Completion
2026-10-19
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))

NCT05567796 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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