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NCT05636176 (ziltivekimab in Heart Failure With Mildly Reduced or…): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 7 Sep 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05636176
Acronym
HERMES
Drug Name
ziltivekimab
Drug MoA
IL-6 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Human Patients
4899
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1526

Prospective Prediction
Prediction Index
1526
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC with inferior-to-semaglutide efficacy in MACE and KCCQ)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit to SoC in MACE and KCCQ)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
897 days in advance
Readout Data Interpretation
ziltivekimab deemed unlikely to succeed by the data monitoring committee and was discontinued further development
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Phase
Phase 3
Status
Terminated
Enrollment
4899
Lead sponsor
Novo Nordisk A/S
Conditions
Heart Failure
Interventions
DRUG: Ziltivekimab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-05-08
Primary completion
2026-09-03
Completion
2026-09-03
Primary outcomes
  • Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit (From randomisation (month 0) to end of study (up to 48 months))

NCT05636176 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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