A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension (KARDINAL)
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Monthly Subcutaneous Administration of Tonlamarsen in Participants With Uncontrolled Hypertension (KARDINAL)
1 other identifier
interventional
206
1 country
39
Brief Summary
The purpose of this study is to evaluate the blood pressure (BP)-lowering efficacy of tonlamarsen in adult participants who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (BP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hypertension
Started Apr 2025
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 7, 2025
CompletedStudy Start
First participant enrolled
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2026
CompletedMarch 31, 2026
March 1, 2026
9 months
February 12, 2025
March 28, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
To assess the effect of tonlamarsen on plasma angiotensinogen (AGT) levels
Percent Change from baseline (Week 0) in plasma angiotensinogen (AGT) levels to Week 20
Week 20
To assess the systolic blood pressure-lowering efficacy of tonlamarsen
Change from baseline (Week 0) in mean office seated systolic blood pressure to Week 20
Week 20
Secondary Outcomes (5)
To assess the safety and tolerability of tonlamarsen
Week 28
To assess the efficacy of tonlamarsen in achieving office seated systolic blood pressure <130 mmHg
Week 20
To assess the systolic blood pressure-lowering efficacy of tonlamarsen
Week 20
To assess the effect of tonlamarsen on severe systolic blood pressure elevations
Week 20
To assess the diastolic blood pressure-lowering efficacy of tonlamarsen
Week 20
Study Arms (2)
Tonlamarsen
EXPERIMENTAL1 dose of placebo and 5 doses of active drug will be administered by subcutaneous (SC) injection
Placebo
PLACEBO COMPARATOR5 doses of placebo and 1 dose of active drug will be administered by subcutaneous (SC) injection
Interventions
Tonlamarsen will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
Placebo will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
Eligibility Criteria
You may qualify if:
- Age 18 to 80, body weight ≥ 50 kg
- Has uncontrolled hypertension while receiving between 2 and 5 antihypertensive medications prescribed for hypertension
- Has mean office seated systolic blood pressure \> 135 to ≤ 170 mmHg
You may not qualify if:
- Has known history of secondary hypertension
- Has documented history of poor adherence to antihypertensive medication
- Has unstable/underlying known cardiovascular disease
- Has abnormal thyroid function with clinical significance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kardigan, Inc.lead
Study Sites (39)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
Cardiology and Medicine Clinic
Little Rock, Arkansas, 72204, United States
North Coast Cardiology
Encinitas, California, 92024, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Clinical Trials Research
Lincoln, California, 95648, United States
American Institute of Research
Los Angeles, California, 90017, United States
Homestead Associates in Research, Inc.
Homestead, Florida, 33033, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328, United States
Velocity Clinical Reseach
Savannah, Georgia, 31406, United States
Eagle Clinical Research
Chicago, Illinois, 60621, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
Koch Family Medicine Clinical Research
Morton, Illinois, 61550, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, 70072, United States
IMA Clinical Research
Monroe, Louisiana, 71201, United States
DelRicht Clinical Research - New Orleans
New Orleans, Louisiana, 70115, United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, 01844, United States
Oakland Medical Research Center
Troy, Michigan, 48085, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
CHEAR Center LLC
The Bronx, New York, 10455, United States
IMA Clinical Research
Lenoir, North Carolina, 28645, United States
Clinical Trials of South Carolina
Moncks Corner, South Carolina, 29461, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Advanced Medical Trials, LLC
Georgetown, Texas, 78628, United States
Juno Research, LLC
Houston, Texas, 77040, United States
Radiance Clinical Research
Lampasas, Texas, 76550, United States
Synergy Groups Medical, LLC
Missouri City, Texas, 77459, United States
North Hills Medical Research
North Richland Hills, Texas, 76180, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
York Clinical Research LLC
Norfolk, Virginia, 23504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2025
First Posted
March 7, 2025
Study Start
April 10, 2025
Primary Completion
January 12, 2026
Study Completion
March 17, 2026
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share