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NCT06272487 (Zilebesiran in Uncontrolled hypertension): BVCT ex-ante prediction vs. reported outcome

On 6 May 2025, BioinvestGPT's BVCT predicted technical partial failure and commercial partial failure for this trial. The 30 Aug 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient (inferior to baxdrostat).

Clinical Trial

NCTID
NCT06272487
Acronym
KARDIA-3
Drug Name
Zilebesiran
Drug MoA
GalNAc-conjugated siRNA against liver-expressed AGT
Drug Modality
siRNA
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Uncontrolled hypertension
Human Patients
375
Sponsor
Alnylam Pharmaceuticals / Roche
Phase
Phase 2

Prediction of , index 2008

Prospective Prediction
Prediction Index
2008
Prediction Date
Commercial Prediction
partial FAILURE (commercially maybe sufficient yet very weak additive clinical benefit to SoC in seated SBP moderately inferior to low-dose baxdrostat/lorundrostat + SoC)
Technical Prediction
partial FAILURE (statistically maybe significant yet very weak additive clinical benefit to SoC in seated SBP compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
116 days in advance
Readout Data Interpretation
zilebesiran didn’t achieve statistical significance with 5.0 mmHg placebo-adjusted reduction in seated SBP at week 12 for uncontrolled hypertension (p=0.0431); moderately inferior to baxdrostat that achieved 9.8 mmHg placebo-adjusted reduction in seated SBP at week 12 for uncontrolled or resistant hypertension (p<0.001) (see add'l link below and DOI-10.1016/j.ejim.2023.04.021)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient (inferior to baxdrostat)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications
Phase
Phase 2
Status
Completed
Enrollment
375
Lead sponsor
Alnylam Pharmaceuticals
Conditions
High Cardiovascular Risk; Hypertension
Interventions
DRUG: Zilebesiran; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-02-29
Primary completion
2025-06-19
Completion
2025-12-01
Primary outcomes
  • Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) (Baseline and Month 3)

NCT06272487 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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