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NCT03914326 (Semaglutide in Cardiovascular Outcomes with Type 2 Diabetes): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 21 Oct 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT03914326
Acronym
SOUL
Drug Name
Semaglutide
Drug MoA
GLP1R agonist
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases and Nutritional and Metabolic Diseases
Indication
Cardiovascular Outcomes with Type 2 Diabetes
Human Patients
9651
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1532

Prospective Prediction
Prediction Index
1532
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
211 days in advance
Readout Data Interpretation
Semaglutide achieved 14% placebo-adjusted reduction in MACE (no FDA-approved SoC)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
Phase
Phase 3
Status
Completed
Enrollment
9651
Lead sponsor
Novo Nordisk A/S
Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG: Semaglutide; DRUG: Placebo (semaglutide)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-06-17
Primary completion
2024-08-23
Completion
2024-08-23
Results first posted
2025-09-22
Primary outcomes
  • Number of Participants From Randomization to First Occurrence of a Major Adverse Cardiovascular Event (MACE), a Composite Endpoint Consisting of: Cardiovascular (CV) Death/Non-fatal Myocardial Infarction/Non-fatal Stroke (From randomisation (week 0) up to week 265)

NCT03914326 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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