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NCT06200207 (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

Acronym
ATHENA
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
680
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1525

Prospective Prediction
Prediction Index
1525
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC with inferior-to-semaglutide efficacy in KCCQ-CSS and 6MWD)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit to SoC in KCCQ-CSS and 6MWD)

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 Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Phase
Phase 3
Status
Active not recruiting
Enrollment
680
Lead sponsor
Novo Nordisk A/S
Conditions
Heart Failure; Systemic Inflammation
Interventions
DRUG: Ziltivekimab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-04-01
Primary completion
2026-10-01
Completion
2027-01-08
Primary outcomes
  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) (From randomisation (month 0) to end-of-treatment (month 12))

NCT06200207 on ClinicalTrials.gov

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