Tonlamarsen to lower blood pressure after a hospital stay for acute severe hypertension.
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kardigan, Inc. Industry-sponsored |
| Locations | 4 sites (Arvada, Colorado and 3 other locations) |
| Trial ID | NCT07511361 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Age 18 or older, body weight ≥ 50 kg * Recently discharged from the hospital to home within the past 3 days during which evaluation and/or treatment of acute severe hypertension (documented systolic blood pressure \>180 mmHg and/or diastolic \>110 mmHg) occurred, as measured by a healthcare provider within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization * At Screening and Randomization visit, average systolic blood pressure \> 145 mmHg * Presence of established cardiovascular or renal comorbidities Key Exclusion Criteria: * Has known history of secondary hypertension * Any malignancy requiring treatment within 5 years * Has abnormal thyroid function with clinical significance * Recent hospitalization for stroke, type 1 myocardial infarction or coronary revascularization within 3 months prior to the first on-study visit * 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 this trial is running
Arvada, Colorado and 3 other locations
- Western Nephrology and Metabolic Bone Disease, PC - Arvada — Arvada, Colorado, United States (Not_yet_recruiting)
- Homestead Associates in Research — Homestead, Florida, United States (Recruiting)
- Progressive Medical Research — Port Orange, Florida, United States (Recruiting)
- Chattanooga Research & Medicine CHARM — Chattanooga, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Kardigan Clinical Study Information Team
- Email: clinicaltrials@kardigan.bio
- Phone: +1-877-310-5135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.