A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension
NCT ID: NCT04936035
Last Updated: 2024-12-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
394 participants
INTERVENTIONAL
2021-07-07
2024-12-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received zilebesiran matching placebo, subcutaneous (SC) injection, once every 3 months (Q3M), with re-randomization at Month 6 to 1 of the initial 4 zilebesiran regimens. Participants will continue their respective zilebesiran regimen up to Month 12 in the DB period and up to 24 additional months in the DB Extension period. Upon implementation of Amendment 6, the DB Extension period was closed.
Placebo
Placebo administered by SC injection
ALN-AGT01
ALN-AGT01 administered by SC injection
Zilebesiran 150 Milligrams (mg) Once Every 6 Months (Q6M)
Participants receive zilebesiran, 150 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed.
Placebo
Placebo administered by SC injection
ALN-AGT01
ALN-AGT01 administered by SC injection
Zilebesiran 300 mg Q6M
Participants receive zilebesiran, 300 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed.
Placebo
Placebo administered by SC injection
ALN-AGT01
ALN-AGT01 administered by SC injection
Zilebesiran 300 mg Q3M
Participants receive zilebesiran, 300 mg, SC injection, Q3M, during the 12-month DB period. Participants continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Upon implementation of Amendment 6, the DB Extension period was closed.
ALN-AGT01
ALN-AGT01 administered by SC injection
Zilebesiran 600 mg Q6M
Participants receive zilebesiran, 600 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed.
Placebo
Placebo administered by SC injection
ALN-AGT01
ALN-AGT01 administered by SC injection
Interventions
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Placebo
Placebo administered by SC injection
ALN-AGT01
ALN-AGT01 administered by SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
* Elevated potassium \>5 mEq/L
* Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m\^2
* Received an investigational agent within the last 30 days
* Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus
* History of any cardiovascular event within 6 months prior to randomization
* History of intolerance to SC injection(s)
18 Years
75 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Birmingham, Alabama, United States
Clinical Trial Site
Tempe, Arizona, United States
Clinical Trial Site
Tempe, Arizona, United States
Clinical Trial Site
Beverly Hills, California, United States
Clinical Trial Site
La Mesa, California, United States
Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
San Diego, California, United States
Clinical Trial Site
South Gate, California, United States
Clinical Trial Site
Vista, California, United States
Clinical Trial Site
Washington D.C., District of Columbia, United States
Clinical Trial Site
Clearwater, Florida, United States
Clinical Trial Site
Coral Gables, Florida, United States
Clinical Trial Site
Fleming Island, Florida, United States
Clinical Trial Site
Hollywood, Florida, United States
Clinical Trial Site
Hollywood, Florida, United States
Clinical Trial Site
Inverness, Florida, United States
Clinical Trial Site
Jacksonville, Florida, United States
Clinical Trial Site
Jacksonville, Florida, United States
Clinical Trial Site
Jacksonville, Florida, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Naples, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Clinical Trial Site
Acworth, Georgia, United States
Clinical Trial Site
Columbus, Georgia, United States
Clinical Trial Site
Fayetteville, Georgia, United States
Clinical Trial Site
Macon, Georgia, United States
Clinical Trial Site
Champaign, Illinois, United States
Clinical Trial Site
Valparaiso, Indiana, United States
Clinical Trial Site
West Des Moines, Iowa, United States
Clinical Trial Site
Lake Charles, Louisiana, United States
Clinical Trial Site
New Orleans, Louisiana, United States
Clinical Trial Site
Prairieville, Louisiana, United States
Clinical Trial Site
Baltimore, Maryland, United States
Clinical Trial Site
Jackson, Mississippi, United States
Clinical Trial Site
Jefferson City, Missouri, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
Clinical Trial Site
The Bronx, New York, United States
Clinical Trial Site
Greensboro, North Carolina, United States
Clinical Trial Site
Greensboro, North Carolina, United States
Clinical Trial Site
Medford, Oregon, United States
Clinical Trial Site
Greenville, South Carolina, United States
Clinical Trial Site
Memphis, Tennessee, United States
Clinical Trial Site
Cedar Park, Texas, United States
Clinical Trial Site
Houston, Texas, United States
Clinical Trial Site
Houston, Texas, United States
Clinical Trial Site
Magnolia, Texas, United States
Clinical Trial Site
Pearland, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
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Stephenville, Texas, United States
Clinical Trial Site
Tomball, Texas, United States
Clinical Trial Site
Waco, Texas, United States
Clinical Trial Site
Burke, Virginia, United States
Clinical Trial Site
Red Deer, Alberta, Canada
Clinical Trial Site
New Minas, Nova Scotia, Canada
Clinical Trial Site
Brampton, Ontario, Canada
Clinical Trial Site
Toronto, Ontario, Canada
Clinical Trial Site
Chicoutimi, Quebec, Canada
Clinical Trial Site
Mirabel, Quebec, Canada
Clinical Trial Site
Montreal, Quebec, Canada
Clinical Trial Site
Québec, Quebec, Canada
Clinical Trial Site
Trois-Rivières, Quebec, Canada
Clinical Trial Site
Victoriaville, Quebec, Canada
Clinical Trial Site
Bayamón, , Puerto Rico
Clinical Trial Site
Ponce, , Puerto Rico
Clinical Trial Site
San Juan, , Puerto Rico
Clinical Trial Site
Ivano-Frankivsk, , Ukraine
Clinical Trial Site
Kharkiv, , Ukraine
Clinical Trial Site
Odesa, , Ukraine
Clinical Trial Site
Uzhhorod, , Ukraine
Clinical Trial Site
Glasgow, , United Kingdom
Clinical Trial Site
Hexham, , United Kingdom
Clinical Trial Site
London, , United Kingdom
Clinical Trial Site
Manchester, , United Kingdom
Countries
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References
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Bakris GL, Saxena M, Gupta A, Chalhoub F, Lee J, Stiglitz D, Makarova N, Goyal N, Guo W, Zappe D, Desai AS; KARDIA-1 Study Group. RNA Interference With Zilebesiran for Mild to Moderate Hypertension: The KARDIA-1 Randomized Clinical Trial. JAMA. 2024 Mar 5;331(9):740-749. doi: 10.1001/jama.2024.0728.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-001248-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALN-AGT01-002
Identifier Type: -
Identifier Source: org_study_id