BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04916470 (Semaglutide in Heart Failure With Preserved Ejection Fraction…): BVCT ex-ante prediction vs. reported outcome

On 23 Mar 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 7 Apr 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (placebo) yet commercially insufficient (small 6MWD; Novo Nordisk decided not to file an NDA for marketing approval).

Clinical Trial

NCTID
NCT04916470
Acronym
STEP HFpEF DM
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
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus Type 2
Human Patients
610
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1512

Prospective Prediction
Prediction Index
1512
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in KCCQ and 6MWD as an adjunctive therapy)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in KCCQ and 6MWD as an adjunctive therapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
15 days in advance
Readout Data Interpretation
7.3 point improvement in KCCQ-CSS (5 is the minimum clinically meaningful standard) & 14.3m improvement in 6MWD vs 80m as sufficient for an quality-of-life improvement (Morbach et al. 2024 Clinical Research In Cardiology); 25m as clinically meaningful improvement (Jain et al. Arnold 2021 Circulation Heart Failure).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (placebo) yet commercially insufficient (small 6MWD; Novo Nordisk decided not to file an NDA for marketing approval)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Effect of Semaglutide 2.4 mg Once-weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction, and Type 2 Diabetes
Phase
Phase 3
Status
Completed
Enrollment
617
Lead sponsor
Novo Nordisk A/S
Conditions
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
Interventions
DRUG: Semaglutide; DRUG: Placebo (Semaglutide)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-06-15
Primary completion
2023-10-11
Completion
2023-10-11
Primary outcomes
  • Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score (From baseline (week 0) to end of treatment (week 52))
  • Change in body weight (From baseline (week 0) to end of treatment (week 52))

NCT04916470 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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