BioinvestGPT ApS · Research use only

NCT05646706 (Semaglutide in Obesity): BVCT ex-ante prediction vs. reported outcome

On 3 Dec 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 17 Jan 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably sufficient.

Clinical Trial

Acronym
STEP UP
Drug Name
Semaglutide
Drug MoA
GLP1R agonist
Drug Modality
peptide
Drug Class
Best-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases
Indication
Obesity
Human Patients
1407
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1851

Prospective Prediction
Prediction Index
1851
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in overall/stratified weight reduction superior to semaglutide 2.4mg; superior to tirzepatide; yet inferior to VK2735)
Technical Prediction
SUCCESS (statistically significant clinical benefit in overall/stratified weight reduction against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
45 days in advance
Readout Data Interpretation
semaglutide 7.2mg achieved 18.3% placebo-adjusted weight reduction at week 72; thus superior to 15.1% placebo-adjusted weight reduction at week 72 achieved by semaglutide 2.4mg (higher than 12.5% placebo-adjusted weight reduction at week 68 achieved by semaglutide 2.4mg in the pivotal trial DOI-10.1056/NEJMoa2032183); inferior to 20.1% placebo-adjusted weight reduction at week 72 achieved by tirzepatide
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity
Phase
Phase 3
Status
Completed
Enrollment
1407
Lead sponsor
Novo Nordisk A/S
Conditions
Obesity
Interventions
DRUG: Semaglutide; DRUG: Semaglutide; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-01-04
Primary completion
2024-10-30
Completion
2024-11-26
Results first posted
2026-04-23
Primary outcomes
  • Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight (Baseline (week 0), End of treatment (week 72))
  • Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) (At week 72)

NCT05646706 on ClinicalTrials.gov

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