A Phase 3 interventional study of Zilebesiran and Placebo in High Risk Cardiovascular Disease, Hypertension and High Cardiovascular Risk, sponsored by Alnylam Pharmaceuticals. Recruiting at 1,190 sites in 35 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Alnylam Pharmaceuticals · Phase 3, Interventional, and Treatment
Among 2,029 studies in Hypertension with a site in United States — 273 open to participants now, 369 under way, 16 of them phase 3. Hypertension · United States.
Among the 2,029 studies in Hypertension with a site in United States, this one is the 25th largest by planned enrollment of the 1,777 interventional ones that give a count, is one of 99 that started in 2025, is one of 202 in phase 3, reaches primary completion later than 348 of the 367 other live ones, and was the 1,921st registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
Browse Hypertension studies →273 of the 2,029 studies in Hypertension with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt University Medical Center · Sites in United States
University of California, San Francisco · Sites in United States
University of Alabama at Birmingham · Sites in United States
The University of Texas at Arlington · Sites in United States
University of Washington · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,029 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 147 · Phase 2 216 · Phase 3 214 · Phase 4 188
First in 1973; this study’s year is marked. 99 started in 2025.
This study's planned enrollment of 11,000 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Median enrollment 100 across the 1,777 interventional studies, 200 across the 238 observational. Of the 1,511 that completed or were terminated, 577 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
461 of 2,029 have an industry lead sponsor. The 10 most frequent:
Alnylam Pharmaceuticals is the lead sponsor of 84 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
Alnylam Pharmaceuticals has 7 studies filed under Hypertension — fewer than ten, so there is no comparison to draw.
142 of the studies in Hypertension with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT04971720Phase 3University of Alabama at BirminghamPRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis | 2027-01-01 |
| NCT06948422Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening) | 2027-09 |
| NCT06948435Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 | 2027-09 |
| NCT06952530Phase 3Eli Lilly and CompanyA Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL2 | 2027-09 |
Among the 2,029 studies in Hypertension with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications.
Drug: Zilebesiran
Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications.
Drug: Placebo
Zilebesiran will be administered SC
Also known as: ALN-AGT01
Placebo will be administered SC
Time to First Occurrence of a Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Heart Failure (HF) Event (Hospitalization for HF or Urgent HF Visit)
Time frame: Up to approximately 5 years
Change from Baseline in Mean Seated Office Systolic Blood Pressure (SBP) at Month 6
Time frame: Baseline and Month 6
Time to First Occurrence of a Composite Endpoint of CV Death, Nonfatal MI, or Nonfatal Stroke
Time frame: Up to approximately 5 years
Composite Endpoint of CV Death and Total (First and Subsequent) HF Events (Hospitalization for HF or Urgent HF Visit)
Time frame: Up to approximately 5 years
Time to First Occurrence of Composite Endpoint of CV death, Nonfatal MI, Nonfatal Stroke, or Coronary Revascularization
Time frame: Up to approximately 5 years
Time to All-cause Death
Time frame: Up to approximately 5 years
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Showing the first 100 of 1,190 sites across 35 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Phase 2-4 trials: Access to anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Sep 2030, 60 months after the start.
Of 95 industry-sponsored phase 3 interventional studies under Hypertension, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 60 months is above that.
Counting every sponsor, half of 141 studies reached it within 21 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Zilebesiran