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Study of Tonlamarsen for Acute Severe Hypertension

This study is testing an investigational medication called tonlamarsen for adults who were recently hospitalized for acute severe hypertension (very high blood pressure). Researchers want to see if tonlamarsen can help lower blood pressure and how safe it is compared to a placebo (an inactive substance). Tonlamarsen works by blocking a protein in the body called angiotensinogen (AGT) that helps control blood pressure. To join, you must be 18 or older, weigh at least 50 kg, and have been recently discharged from the hospital (within 7 days) after experiencing acute severe hypertension. The study aims to measure tonlamarsen's effect on AGT levels and blood pressure, as well as its safety. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 140 participants. Participants will be randomly assigned to receive either tonlamarsen or a placebo.
What's involved
You would receive monthly doses of tonlamarsen for about 3 months and visit the clinic approximately 7 times for evaluations, checkups, and tests.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Week 4 and Week 12, suggesting follow-up for at least 12 weeks.

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NCT07511361

Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension

Recruiting
PHASE2Ages 18+InterventionalTreatment
Kardigan, Inc.
~140 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:TonlamarsenPlacebo

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions
Measured over Baseline through Week 12
+1 more outcome measured

Conditions

Hypertension
Acute Severe Hypertension
Hypertensive Emergency
Hypertensive Urgency

Explore related trials

Hypertension, severeHypertensive EmergencyHypertensive Urgency

Where it's being run

8 sites across 6 states
Florida2
Texas2
Colorado1
New York1
Ohio1
Tennessee1

Who to contact

Kardigan Clinical Study Information Team
[email protected]
+1-877-310-5135
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptionsBaseline through Week 12

    * Change from baseline in plasma angiotensinogen (AGT) levels and systolic blood pressure * Variability in plasma AGT levels and systolic blood pressure

  • Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levelsWeek 4

    Percent change in plasma AGT levels from Baseline to Week 4