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NCT05021835 (ziltivekimab in Established Atherosclerotic Cardiovascular Disease, Chronic Kidney…): 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 31 Jul 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
NCT05021835
Acronym
ZEUS
Drug Name
ziltivekimab
Drug MoA
IL-6 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation
Human Patients
6385
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1524

Prospective Prediction
Prediction Index
1524
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC with inferior-to-semaglutide efficacy in MACE)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit to SoC in MACE reduction)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
859 days in advance
Readout Data Interpretation
ziltivekimab failed to the primary endpoint of placebo-adjusted MACE risk reduction (HR = 0.99), which is inferior to placebo-adjusted MACE risk reduction achieved by semaglutide (HR = 0.80 P < 0.001) for non-diabetic obese/overweight patients with established cardiovascular disease (see add'l link below)
Press Release
Additional Readout Data
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
ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation
Phase
Phase 3
Status
Completed
Enrollment
6385
Lead sponsor
Novo Nordisk A/S
Conditions
Cardiovascular Risk; Chronic Kidney Disease; Inflammation
Interventions
DRUG: Ziltivekimab B; DRUG: Ziltivekimab C; DRUG: Placebo (Ziltivekimab B); DRUG: Placebo (Ziltivekimab C)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-08-30
Primary completion
2026-06-09
Completion
2026-06-09
Primary outcomes
  • Time to first occurrence of 3-point Major Adverse Cardiovascular Event (MACE), a composite endpoint consisting of: Cardiovascular (CV) death, non-fatal Myocardial Infarction (MI) and non-fatal stroke (From randomisation (month 0) to end-of-study (up to 48 months))

NCT05021835 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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