> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/zilebesiran-as-add-on-therapy-in-patients-with-high-99e797f0-69a2-43a5-ad39-90a5c2e4b72f > Record changed: 2026-10-13 # Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) NCT06272487 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) Participants 375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) Lead sponsor Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) Start date 2024-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) Number of sites 195 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Title and summary **Summary** The purpose of this study is to evaluate the effect of zilebesiran as add-on therapy in patients with high cardiovascular risk and hypertension not adequately controlled by standard of care antihypertensive medications. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Acronym** KARDIA-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Short title** Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Dates **Completion date** 2025-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **First posted** 2024-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Registry last updated** 2026-03-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Primary completion date** 2025-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Start date** 2024-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Size and sites **Actual participants** 375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Participants** 375 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Number of sites** 195 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Lead sponsor** Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Identifiers **Registry ID** NCT06272487 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **ClinicalTrials.gov ID** NCT06272487 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Outcomes ### Primary outcomes 1. Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) Timeframe: Baseline and Month 3 ### Secondary outcomes 1. Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) Timeframe: Baseline and Month 3 2. Change from Baseline at Month 6 in Mean Seated Office SBP Timeframe: Baseline and Month 6 3. Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM Timeframe: Baseline and Month 6 4. Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 Timeframe: Month 6 5. Proportion of Patients with 24-hour Mean SBP assessed by ABPM <130 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 Timeframe: Month 6 6. Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM Timeframe: Baseline and Months 3 and 6 7. Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP Timeframe: Baseline and Months 3 and 6 8. Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM Timeframe: Baseline and Months 3 and 6 9. Change from Baseline Over Time in Serum Angiotensinogen (AGT) Timeframe: Baseline through Month 6 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - History of cardiovascular (CV) disease, high CV risk, or estimated glomerular filtration rate (eGFR) ≥30 to <60 mL/min/1.73m^2 - Mean seated office SBP ≥140 mmHg and ≤170 mmHg - 24-hour mean SBP ≥130 mmHg and ≤170 mmHg assessed by ABPM - Must be on stable therapy with 2 to 4 classes of antihypertensive medications ### Exclusion criteria - Secondary hypertension - Orthostatic hypotension - Proteinuria >3 g/day - Serum potassium >4.8 milliequivalents per liter (mEq/L) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Sites - Clinical Trial SiteAlexander City, United States - Clinical Trial SiteDaphne, United States - Clinical Trial SiteFoley, United States - Clinical Trial SiteHuntsville, United States - Clinical Trial SiteHuntsville, United States - Clinical Trial SiteMontgomery, United States - Clinical Trial SiteGilbert, United States - Clinical Trial SitePhoenix, United States - Clinical Trial SiteSun City, United States - Clinical Trial SiteTempe, United States - Clinical Trial SiteTucson, United States - Clinical Trial SiteBeverly Hills, United States - Clinical Trial SiteCovina, United States - Clinical Trial SiteEncinitas, United States - Clinical Trial SiteGarden Grove, United States - Clinical Trial SiteHuntington Beach, United States - Clinical Trial SiteLos Angeles, United States - Clinical Trial SiteLos Angeles, United States - Clinical Trial SiteNorthridge, United States - Clinical Trial SiteNorthridge, United States - Clinical Trial SitePasadena, United States - Clinical Trial SiteSan Diego, United States - Clinical Trial SiteSan Diego, United States - Clinical Trial SiteSan Dimas, United States - Clinical Trial SiteSimi Valley, United States And 170 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06272487) ## Related records ### Drugs (1) - [Zilebesiran](https://trialight.com/data/asset/zilebesiran-b4435c9a-5472-4cb5-bf04-782893e8980e.md) ### Lead sponsors (1) - [Alnylam Pharmaceuticals](https://trialight.com/data/company/alnylam-pharmaceuticals-37379b27-2f42-476c-879b-9773955a515f.md) ### Conditions (2) - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) - [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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