BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04255433 (Tirzepatide in Type 2 Diabetes Mellitus and heart…): BVCT ex-ante prediction vs. reported outcome

On 18 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 31 Jul 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (numerically superior to dulaglutide) and commercially sufficient (numerically superior to semaglutide).

Clinical Trial

NCTID
NCT04255433
Acronym
SURPASS-CVOT
Drug Name
Tirzepatide
Drug MoA
GLP1R/GIPR dual agonist
Drug Modality
peptide
Drug Class
Best-In-Class
Therapeutic Area
Cardiovascular Diseases and Nutritional and Metabolic Diseases
Indication
Type 2 Diabetes Mellitus (T2DM) and heart disease
Human Patients
13299
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 727

Prospective Prediction
Prediction Index
727
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit superior to dulaglutide in MACE-3 endpoint for obese diabetic cardiovascular patients)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
529 days in advance
Readout Data Interpretation
Tirzepatide achieved 8% dulaglutide-adjusted reduction in MACE-3 (HR = 0.92 p=0.086); 16% dulaglutide-adjusted reduction in time to all-cause death (HR=0.84; p=0.002); and 28% placebo-adjusted reduction in MACE-3 (HR = 0.72); superior to semaglutide’s 20% placebo-adjusted reduction in MACE-3 in SELECT trial (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (numerically superior to dulaglutide) and commercially sufficient (numerically superior to semaglutide)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
The Effect of Tirzepatide Versus Dulaglutide on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes (SURPASS-CVOT)
Phase
Phase 3
Status
Completed
Enrollment
13299
Lead sponsor
Eli Lilly and Company
Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG: Tirzepatide; DRUG: Dulaglutide
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-05-29
Primary completion
2025-06-12
Completion
2025-06-12
Results first posted
2026-07-08
Primary outcomes
  • Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke] (From randomization (week 0) up to week 259)

NCT04255433 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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