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NCT05103332 (Zilebesiran Olmesartan Amlodipine Indapamide in Hypertension): BVCT ex-ante prediction vs. reported outcome

On 15 Dec 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 7 Apr 2024 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
NCT05103332
Acronym
KARDIA-2
Drug Name
Zilebesiran Olmesartan Amlodipine Indapamide
Drug MoA
anti-AGT siRNA
Drug Modality
small interfering RNA (siRNA) antisense oligonucleotide
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Hypertension
Human Patients
672
Sponsor
Alnylam Pharmaceuticals
Phase
Phase 2

Prediction of , index 1376

Prospective Prediction
Prediction Index
1376
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
114 days in advance
Readout Data Interpretation
statistically insignificant changes in 24-Hour Mean SBP for the SoC olmesartan ((p=0.036 by phase 3 standard; Paz et al. Coll-de-Tuero 2016 Medicine; Chrysant et al. Robinson 2003 J of Human Hypertension) in both primary/secondary endpoints.
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
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication
Phase
Phase 2
Status
Completed
Enrollment
663
Lead sponsor
Alnylam Pharmaceuticals
Conditions
Hypertension
Interventions
DRUG: Indapamide; DRUG: Amlodipine; DRUG: Olmesartan; DRUG: Placebo; DRUG: Zilebesiran
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-11-05
Primary completion
2023-12-11
Completion
2024-09-13
Results first posted
2025-07-09
Primary outcomes
  • Indapamide: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data (Baseline and Month 3)
  • Amlodipine: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data (Baseline and Month 3)
  • Olmesartan: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM - Censored Data (Baseline and Month 3)

NCT05103332 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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