BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04847557 (Tirzepatide in Heart Failure With Preserved Ejection Fraction…): BVCT ex-ante prediction vs. reported outcome

On 17 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 16 Nov 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
NCT04847557
Acronym
SUMMIT
Drug Name
Tirzepatide (LY3298176)
Drug MoA
GLP1R/GIPR-biased dual agonist
Drug Modality
synthetic peptide
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases and Nutritional and Metabolic Diseases
Indication
Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity
Human Patients
731
Sponsor
Eli Lilly and Company
Phase
Phase 3

Prediction of , index 1684

Prospective Prediction
Prediction Index
1684
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit in 6MWD superior to semaglutide as an adjunctive therapy)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in KCCQ/mortality/heart failure as an adjunctive therapy)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
122 days in advance
Readout Data Interpretation
-38% risk reduction in composite endpoint (DOI- 10.1056/NEJMoa2410027) and 6.8-9.8 point improvement in KCCQ-CSS by week 52 (vs 7.5 by week 52 for semaglutide in Butler et al. 2024 LANCET); 30.3m and 15.9m placebo-adjusted efficacy/regimen 6WMD (vs 18.2m and 14.3m achieved by semaglutide by week 52 Butler et al. 2024 LANCET)
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
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
Phase
Phase 3
Status
Completed
Enrollment
731
Lead sponsor
Eli Lilly and Company
Conditions
Obesity; Heart Failure With Preserved Ejection Fraction (HFpEF)
Interventions
DRUG: Tirzepatide; OTHER: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-04-20
Primary completion
2024-07-02
Completion
2024-07-02
Results first posted
2025-08-20
Primary outcomes
  • Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) (Baseline, Week 52)
  • First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes (Baseline Up To 160 weeks)

NCT04847557 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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