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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zilebesiran | Experimental | Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period. |
|
| Placebo | Placebo Comparator | Participants will receive placebo on Day 1 of the 6-month DB treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zilebesiran | Drug | Zilebesiran administered by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline at Month 3 in Mean Seated Office Systolic Blood Pressure (SBP) | Baseline and Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline at Month 3 in 24-Hour Mean SBP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) | Baseline and Month 3 | |
| Change from Baseline at Month 6 in Mean Seated Office SBP | Baseline and Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Alexander City | Alabama | 35010 | United States | ||
| Clinical Trial Site |
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.
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| Placebo | Drug | Placebo administered by SC injection |
|
| Change from Baseline at Month 6 in 24-Hour Mean SBP Assessed by ABPM | Baseline and Month 6 |
| Proportion of Patients with Mean Seated Office SBP <140 mmHg and/or Reduction ≥10 mmHg without Intensification of Antihypertensive Regimen at Month 6 | Month 6 |
| 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 | Month 6 |
| Change from Baseline at Month 3 and Month 6 in Daytime and Nighttime Mean SBP and Diastolic Blood Pressure (DBP) assessed by ABPM | Baseline and Months 3 and 6 |
| Change from Baseline at Month 3 and Month 6 in Mean Seated Office DBP | Baseline and Months 3 and 6 |
| Change from Baseline at Month 3 and Month 6 in 24-hour Mean DBP Assessed by ABPM | Baseline and Months 3 and 6 |
| Change from Baseline Over Time in Serum Angiotensinogen (AGT) | Baseline through Month 6 |
| Daphne |
| Alabama |
| 36526 |
| United States |
| Clinical Trial Site | Foley | Alabama | 36535 | United States |
| Clinical Trial Site | Huntsville | Alabama | 35801 | United States |
| Clinical Trial Site | Huntsville | Alabama | 35805 | United States |
| Clinical Trial Site | Montgomery | Alabama | 36117 | United States |
| Clinical Trial Site | Gilbert | Arizona | 85297 | United States |
| Clinical Trial Site | Phoenix | Arizona | 85028 | United States |
| Clinical Trial Site | Sun City | Arizona | 85351 | United States |
| Clinical Trial Site | Tempe | Arizona | 85281 | United States |
| Clinical Trial Site | Tucson | Arizona | 85741 | United States |
| Clinical Trial Site | Beverly Hills | California | 90211 | United States |
| Clinical Trial Site | Covina | California | 91723 | United States |
| Clinical Trial Site | Encinitas | California | 92024 | United States |
| Clinical Trial Site | Garden Grove | California | 92844 | United States |
| Clinical Trial Site | Huntington Beach | California | 92647 | United States |
| Clinical Trial Site | Los Angeles | California | 90022 | United States |
| Clinical Trial Site | Los Angeles | California | 90057 | United States |
| Clinical Trial Site | Northridge | California | 91324 | United States |
| Clinical Trial Site | Northridge | California | 91325 | United States |
| Clinical Trial Site | Pasadena | California | 91105 | United States |
| Clinical Trial Site | San Diego | California | 92108 | United States |
| Clinical Trial Site | San Diego | California | 92111 | United States |
| Clinical Trial Site | San Dimas | California | 91773 | United States |
| Clinical Trial Site | Simi Valley | California | 93065 | United States |
| Clinical Trial Site | Vacaville | California | 95687 | United States |
| Clinical Trial Site | Van Nuys | California | 91405 | United States |
| Clinical Trial Site | West Hills | California | 91307 | United States |
| Clinical Trial Site | Colorado Springs | Colorado | 80918 | United States |
| Clinical Trial Site | Denver | Colorado | 80210 | United States |
| Clinical Trial Site | Denver | Colorado | 80230 | United States |
| Clinical Trial Site | Hartford | Connecticut | 06112 | United States |
| Clinical Trial Site | Middlebury | Connecticut | 06762 | United States |
| Clinical Trial Site | Waterbury | Connecticut | 06708 | United States |
| Clinical Trial Site | Washington D.C. | District of Columbia | 20009 | United States |
| Clinical Trial Site | Clearwater | Florida | 33756 | United States |
| Clinical Trial Site | Coral Gables | Florida | 33134 | United States |
| Clinical Trial Site | Daytona Beach | Florida | 32117 | United States |
| Clinical Trial Site | Fort Myers | Florida | 33912 | United States |
| Clinical Trial Site | Hollywood | Florida | 33021 | United States |
| Clinical Trial Site | Jacksonville | Florida | 32204 | United States |
| Clinical Trial Site | Jacksonville | Florida | 32209 | United States |
| Clinical Trial Site | Jacksonville | Florida | 32256 | United States |
| Clinical Trial Site | Jensen Beach | Florida | 34957 | United States |
| Clinical Trial Site | Lake City | Florida | 32055 | United States |
| Clinical Trial Site | Miami | Florida | 33126 | United States |
| Clinical Trial Site | Miami | Florida | 33135 | United States |
| Clinical Trial Site | Miami | Florida | 33137 | United States |
| Clinical Trial Site | Miami | Florida | 33144 | United States |
| Clinical Trial Site | Miami | Florida | 33155 | United States |
| Clinical Trial Site | Miami | Florida | 33176 | United States |
| Clinical Trial Site | Miramar | Florida | 33027 | United States |
| Clinical Trial Site | Orlando | Florida | 32801 | United States |
| Clinical Trial Site | The Villages | Florida | 32162 | United States |
| Clinical Trial Site | Winter Haven | Florida | 33880 | United States |
| Clinical Trial Site | Acworth | Georgia | 30101 | United States |
| Clinical Trial Site | Atlanta | Georgia | 30322 | United States |
| Clinical Trial Site | Columbus | Georgia | 31904 | United States |
| Clinical Trial Site | Douglasville | Georgia | 30134 | United States |
| Clinical Trial Site | Gainesville | Georgia | 30501 | United States |
| Clinical Trial Site | Savannah | Georgia | 31406 | United States |
| Clinical Trial Site | Thomasville | Georgia | 31792 | United States |
| Clinical Trial Site | Boise | Idaho | 83706 | United States |
| Clinical Trial Site | Chicago | Illinois | 60602 | United States |
| Clinical Trial Site | Elkhart | Indiana | 46514 | United States |
| Clinical Trial Site | Evansville | Indiana | 47714 | United States |
| Clinical Trial Site | Richmond | Indiana | 47374 | United States |
| Clinical Trial Site | El Dorado | Kansas | 67042 | United States |
| Clinical Trial Site | Newton | Kansas | 67114 | United States |
| Clinical Trial Site | Wichita | Kansas | 67207 | United States |
| Clinical Trial Site | Owensboro | Kentucky | 42303 | United States |
| Clinical Trial Site | Monroe | Louisiana | 71201 | United States |
| Clinical Trial Site | New Orleans | Louisiana | 70119 | United States |
| Clinical Trial Site | Boston | Massachusetts | 02114 | United States |
| Clinical Trial Site | West Springfield | Massachusetts | 01089 | United States |
| Clinical Trial Site | Flint | Michigan | 48504 | United States |
| Clinical Trial Site | Shelby | Michigan | 48315 | United States |
| Clinical Trial Site | Ypsilanti | Michigan | 48197 | United States |
| Clinical Trial Site | Minneapolis | Minnesota | 55404 | United States |
| Clinical Trial Site | Richfield | Minnesota | 55423 | United States |
| Clinical Trial Site | Columbus | Mississippi | 39705 | United States |
| Clinical Trial Site | Tupelo | Mississippi | 38801 | United States |
| Clinical Trial Site | Creve Coeur | Missouri | 63141 | United States |
| Clinical Trial Site | Kalispell | Montana | 59901 | United States |
| Clinical Trial Site | Lincoln | Nebraska | 68510 | United States |
| Clinical Trial Site | Omaha | Nebraska | 68114 | United States |
| Clinical Trial Site | Las Vegas | Nevada | 89121 | United States |
| Clinical Trial Site | Portsmouth | New Hampshire | 03801 | United States |
| Clinical Trial Site | Berlin | New Jersey | 08009 | United States |
| Clinical Trial Site | Albuquerque | New Mexico | 87109 | United States |
| Clinical Trial Site | New York | New York | 10017 | United States |
| Clinical Trial Site | Charlotte | North Carolina | 28287 | United States |
| Clinical Trial Site | Durham | North Carolina | 27704 | United States |
| Clinical Trial Site | Durham | North Carolina | 27713 | United States |
| Clinical Trial Site | Greensboro | North Carolina | 27401 | United States |
| Clinical Trial Site | Greenville | North Carolina | 27834 | United States |
| Clinical Trial Site | Monroe | North Carolina | 28112 | United States |
| Clinical Trial Site | Raleigh | North Carolina | 27609 | United States |
| Clinical Trial Site | Wilmington | North Carolina | 28403 | United States |
| Clinical Trial Site | Winston-Salem | North Carolina | 27103 | United States |
| Clinical Trial Site | Cleveland | Ohio | 44106 | United States |
| Clinical Trial Site | Marion | Ohio | 43302 | United States |
| Clinical Trial Site | Norman | Oklahoma | 73072 | United States |
| Clinical Trial Site | Oklahoma City | Oklahoma | 73102 | United States |
| Clinical Trial Site | Bethlehem | Pennsylvania | 18017 | United States |
| Clinical Trial Site | Langhorne | Pennsylvania | 19047 | United States |
| Clinical Trial Site | Newport | Pennsylvania | 17074 | United States |
| Clinical Trial Site | Philadelphia | Pennsylvania | 19114 | United States |
| Clinical Trial Site | East Providence | Rhode Island | 02914 | United States |
| Clinical Trial Site | Myrtle Beach | South Carolina | 29572 | United States |
| Clinical Trial Site | Rapid City | South Dakota | 57701 | United States |
| Clinical Trial Site | Chattanooga | Tennessee | 37404 | United States |
| Clinical Trial Site | Germantown | Tennessee | 38138 | United States |
| Clinical Trial Site | Knoxville | Tennessee | 37909 | United States |
| Clinical Trial Site | Knoxville | Tennessee | 37923 | United States |
| Clinical Trial Site | Memphis | Tennessee | 38119 | United States |
| Clinical Trial Site | Austin | Texas | 78744 | United States |
| Clinical Trial Site | Coppell | Texas | 75019 | United States |
| Clinical Trial Site | Dallas | Texas | 75230 | United States |
| Clinical Trial Site | Dallas | Texas | 75234 | United States |
| Clinical Trial Site | El Paso | Texas | 79925 | United States |
| Clinical Trial Site | El Paso | Texas | 79935 | United States |
| Clinical Trial Site | Houston | Texas | 77002 | United States |
| Clinical Trial Site | Houston | Texas | 77024 | United States |
| Clinical Trial Site | Houston | Texas | 77054 | United States |
| Clinical Trial Site | Houston | Texas | 77081 | United States |
| Clinical Trial Site | Houston | Texas | 77099 | United States |
| Clinical Trial Site | Magnolia | Texas | 77355 | United States |
| Clinical Trial Site | San Antonio | Texas | 78229 | United States |
| Clinical Trial Site | San Antonio | Texas | 78240 | United States |
| Clinical Trial Site | Shenandoah | Texas | 77384 | United States |
| Clinical Trial Site | Sherman | Texas | 75092 | United States |
| Clinical Trial Site | Stephenville | Texas | 76401 | United States |
| Clinical Trial Site | Tomball | Texas | 77375 | United States |
| Clinical Trial Site | Burlington | Vermont | 05401 | United States |
| Clinical Trial Site | Burke | Virginia | 22015 | United States |
| Clinical Trial Site | Manassas | Virginia | 20109 | United States |
| Clinical Trial Site | Norfolk | Virginia | 23504 | United States |
| Clinical Trial Site | West Allis | Wisconsin | 53227 | United States |
| Clinical Trial Site | Blacktown | 2148 | Australia |
| Clinical Trial Site | Brookvale | 2100 | Australia |
| Clinical Trial Site | Bruce | 2617 | Australia |
| Clinical Trial Site | Concord | 2139 | Australia |
| Clinical Trial Site | Garran | 2605 | Australia |
| Clinical Trial Site | Kanwal | 2259 | Australia |
| Clinical Trial Site | Kogarah | 2217 | Australia |
| Clinical Trial Site | Perth | 6000 | Australia |
| Clinical Trial Site | Sippy Downs | 4556 | Australia |
| Clinical Trial Site | St Leonards | 2065 | Australia |
| Clinical Trial Site | Tarragindi | 4121 | Australia |
| Clinical Trial Site | Brampton | L6T 0G1 | Canada |
| Clinical Trial Site | Chicoutimi | G7H 7K9 | Canada |
| Clinical Trial Site | Greenfield Park | J4V 2G8 | Canada |
| Clinical Trial Site | Montreal | H4J 1C5 | Canada |
| Clinical Trial Site | Montreal | H4N 2W2 | Canada |
| Clinical Trial Site | Québec | G1W 4R4 | Canada |
| Clinical Trial Site | Québec | G1V 4T3 | Canada |
| Clinical Trial Site | Sainte-Foy | G1V 4G5 | Canada |
| Clinical Trial Site | Sarnia | N7T 4X3 | Canada |
| Clinical Trial Site | Toronto | M3J 0K2 | Canada |
| Clinical Trial Site | Toronto | M4P 1E4 | Canada |
| Clinical Trial Site | Toronto | M5B 1W8 | Canada |
| Clinical Trial Site | Trois-Rivières | G9A 4P3 | Canada |
| Clinical Trial Site | Waterloo | N2T 0C1 | Canada |
| Clinical Trial Site | Winnipeg | R2V 3M3 | Canada |
| Clinical Trial Site | Ponce | 00716 | Puerto Rico |
| Clinical Trial Site | Toa Baja | 00949 | Puerto Rico |
| Clinical Trial Site | Basel | 4031 | Switzerland |
| Clinical Trial Site | Geneva | 1205 | Switzerland |
| Clinical Trial Site | Lausanne | 1005 | Switzerland |
| Clinical Trial Site | Lucerne | 6000 | Switzerland |
| Clinical Trial Site | Bellshill | ML4 3NJ | United Kingdom |
| Clinical Trial Site | Birmingham | B15 2SQ | United Kingdom |
| Clinical Trial Site | Bristol | BS2 8HW | United Kingdom |
| Clinical Trial Site | Canterbury | CT1 3NG | United Kingdom |
| Clinical Trial Site | Cardiff | CF15 9SS | United Kingdom |
| Clinical Trial Site | Carshalton | SM5 1AA | United Kingdom |
| Clinical Trial Site | Chesterfield | S40 4AA | United Kingdom |
| Clinical Trial Site | Chorley | PR7 7NA | United Kingdom |
| Clinical Trial Site | Fowey | PL23 1DT | United Kingdom |
| Clinical Trial Site | Glasgow | G20 7BE | United Kingdom |
| Clinical Trial Site | Glasgow | G51 4TF | United Kingdom |
| Clinical Trial Site | Hexham | NE46 1QJ | United Kingdom |
| Clinical Trial Site | Leicester | LE5 4PW | United Kingdom |
| Clinical Trial Site | Liskeard | PL14 3XA | United Kingdom |
| Clinical Trial Site | Liverpool | L22 0LG | United Kingdom |
| Clinical Trial Site | London | EC1A 7BE | United Kingdom |
| Clinical Trial Site | London | SE1 1YR | United Kingdom |
| Clinical Trial Site | London | SW17 0QT | United Kingdom |
| Clinical Trial Site | Luton | LU4 0DZ | United Kingdom |
| Clinical Trial Site | Manchester | M15 6SE | United Kingdom |
| Clinical Trial Site | Newquay | TR7 1RU | United Kingdom |
| Clinical Trial Site | Pickering | YO18 8BL | United Kingdom |
| Clinical Trial Site | Plymouth | PL5 3JB | United Kingdom |
| Clinical Trial Site | Torpoint | PL11 2TB | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2026 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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