Tonlamarsen to lower blood pressure after a hospital stay for acute severe hypertension.
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Part Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
Run by Kardigan, Inc. · NCT07511361 · Data updated 2026-11-12
This trial tests whether monthly doses of tonlamarsen can lower blood pressure and reduce angiotensinogen in adults recently discharged after treatment for acute severe hypertension.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Kardigan, Inc. Industry-sponsored |
| Locations | 13 sites (Arvada, Colorado and 12 other locations) |
| Status | Recruiting |
| Started | June 23, 2026 |
| Main results expected | December 2026 |
| Study ends | February 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07511361 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older (≥50 kg) who were discharged home within the past 3 days after treatment for acute severe hypertension, have an average systolic BP >145 mmHg at screening, and have established cardiovascular or renal comorbidities.
✕Probably not a fit
People with known secondary hypertension, recent major cardiovascular events or coronary revascularization, active cancer treatment within 5 years, significant liver disease or clinically significant thyroid abnormalities are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, randomized, placebo-controlled trial of the investigational antisense agent tonlamarsen in adults recently hospitalized for acute severe hypertension. Participants receive approximately three monthly doses and attend about six clinic visits for blood pressure checks, angiotensinogen (AGT) measurements, safety labs, and follow-up. The main outcomes are changes in plasma AGT levels and clinic blood pressure over time, with continuous monitoring for adverse events and tolerability. The trial enrolls adults with established cardiovascular or renal comorbidities who have elevated systolic blood pressure after discharge.
Why it matters
Potential benefit: If effective, tonlamarsen could provide a new monthly treatment to lower blood pressure and reduce the risk of recurrent hypertensive crises after hospital discharge.
How similar studies have gone: Targeting angiotensinogen with RNA-based agents is a relatively new approach for hypertension; related RNA therapies have shown promise in other diseases, but AGT-targeting for blood pressure control remains early and unproven in large clinical trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Age 18 or older, body weight ≥ 50 kg with BMI ≤45.0 kg/m2 * Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and/or treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization * At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg * Presence of established cardiovascular or renal disease Key Exclusion Criteria: * Has known history of secondary hypertension * Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated) * Has abnormal thyroid function with clinical significance * Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening * History of and/or obvious clinical signs or symptoms of cirrhosis or other significant liver disease * Alanine aminotransferase or aspartate aminotransferase \>2 x upper limit of normal * Most recent hospitalization was for non-cardiovascular or non-renal conditions
Where it's running
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Western Nephrology and Metabolic Bone Disease, PC - Arvada
Arvada, Colorado, United States Recruiting -
Homestead Associates in Research
Homestead, Florida, United States Recruiting -
Progressive Medical Research
Port Orange, Florida, United States Recruiting -
Eagle Clinical Research
Chicago, Illinois, United States Recruiting -
Henry Ford Hospital
Detroit, Michigan, United States Recruiting -
Research Innovations, LLC
Beavercreek, Ohio, United States Recruiting
Show 7 more locations
-
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
OnSite Clinical Solutions, LLC
Fort Mill, South Carolina, United States Recruiting -
Chattanooga Research & Medicine CHARM
Chattanooga, Tennessee, United States Recruiting -
Laguna Clinical Research Associates
Laredo, Texas, United States Recruiting -
Tapia Internal Medicine Clinic
Paris, Texas, United States Recruiting -
Baylor Scott and White Research Institute - Temple
Temple, Texas, United States Recruiting -
Richmond University Medical Center (RUMC)
Staten Island, New York, United States Active not recruiting
Study contacts
- Study coordinator: Kardigan Clinical Study Information Team
- Email: clinicaltrials@kardigan.bio
- Phone: +1-877-310-5135
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.