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NCT06131437 (CagriSema in Obesity): BVCT ex-ante prediction vs. reported outcome

On 21 Aug 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 Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (numerically superior to tirzepatide yet probably non-superior to VK2735).

Clinical Trial

NCTID
NCT06131437
Acronym
REDEFINE 4
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
809
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1514

Prospective Prediction
Prediction Index
1514
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in total lean body mass preservation and total fat body mass reduction/change in waist circumference superior to tirzepatide yet non-superior to VK2735 for nondiabetic obese young population)
Technical Prediction
SUCCESS (statistically significant clinical benefit in weight reduction superior to tirzepatide yet non-superior to VK2735 for nondiabetic obese young population)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
121 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; tirzepatide achieved 19.5% placebo-adjusted weight loss at week 68 (DOI- 10.1056/NEJMoa2206038); VK2735 achieved 13.1% placebo-adjusted weight loss at week 13 (see add'l link below); superior to tirzepatide's 7% placebo-adjusted weight loss at week 13 and probably superior to CagriSema’s undisclosed (yet estimated to be 8-10%) placebo-adjusted weight loss at week 13
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (numerically superior to tirzepatide yet probably non-superior to VK2735)
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 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity
Phase
Phase 3
Status
Completed
Enrollment
809
Lead sponsor
Novo Nordisk A/S
Conditions
Obesity
Interventions
DRUG: Cagrilintide; DRUG: Semaglutide; DRUG: Tirzepatide
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-11-27
Primary completion
2025-12-08
Completion
2026-01-09
Primary outcomes
  • To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight (From baseline (week 0) to end of treatment (week 84))

NCT06131437 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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