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NCT07511361PHASE2Recruiting

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

Kardigan, Inc.

Start Date

6/23/2026

Completion Date

2/1/2027

Summary

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently hospitalized and concurrently experienced an episode of acute severe hypertension.

Detailed Description

The Sponsor is studying an investigational medication called tonlamarsen to determine if it can help people recently treated for acute severe hypertension (hypertensive emergency and urgency). The purpose of this study is to evaluate how well tonlamarsen works compared to a placebo and to see how safe it is for people following a recent episode of acute severe hypertension. Tonlamarsen is designed to block the body's liver from making a protein called angiotensinogen (AGT), which plays a key role in controlling blood pressure. The main goals of the study are: * To assess the effect of tonlamarsen on the amount of AGT in blood over time * To assess the effect of tonlamarsen on blood pressure * To evaluate the safety and tolerability of tonlamarsen Participants will: * Receive monthly doses of tonlamarsen for approximately 3 months * Visit the clinic about 7 times, including initial evaluation, checkups, tests, and follow-up

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Tonlamarsen

DRUG

Placebo

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Conditions

HypertensionAcute Severe HypertensionHypertensive EmergencyHypertensive Urgency

Locations

Western Nephrology and Metabolic Bone Disease, PC - Arvada

Arvada, Colorado 80002

United States

Homestead Associates in Research

Homestead, Florida 33033

United States

Progressive Medical Research

Port Orange, Florida 32127

United States

Richmond University Medical Center (RUMC)

Staten Island, New York 10310

United States

Research Innovations, LLC

Beavercreek, Ohio 05431

United States

Chattanooga Research & Medicine CHARM

Chattanooga, Tennessee 37404

United States

Laguna Clinical Research Associates

Laredo, Texas 78041

United States

Baylor Scott and White Research Institute - Temple

Temple, Texas 76502

United States