Recruiting

Phase 2

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

Sponsor:

Kardigan, Inc.

Code:

NCT07511361

Conditions

Hypertension

Acute Severe Hypertension

Hypertensive Emergency

Hypertensive Urgency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tonlamarsen

Placebo

Study Details

Brief 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.

Conditions

Hypertension

Acute Severe Hypertension

Hypertensive Emergency

Hypertensive Urgency

Study ID

NCT07511361

Start date

Jun 23, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tonlamarsen

3 doses active drug will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)

placebo comparator: Placebo

3 doses of placebo will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)

Interventions

Tonlamarsen

Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study

Placebo

Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study

Primary outcome measure

Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions [ Time Frame: Baseline through Week 12 ]
Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Kardigan Clinical Study Information Team

+1-877-310-5135 clinicaltrials@kardigan.bio

Locations

Western Nephrology and Metabolic Bone Disease, PC - Arvada

Recruiting

Arvada, Colorado, United States, 80002

Contacts

Kardigan Clinical Study Information Team

+1-877-310-5135 clinicaltrials@kardigan.bio

Homestead Associates in Research

Recruiting

Homestead, Florida, United States, 33033

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Contacts

Kardigan Clinical Study Information Team

+1-877-310-5135 clinicaltrials@kardigan.bio

Eagle Clinical Research

Recruiting

Chicago, Illinois, United States, 60621

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

Research Innovations, LLC

Recruiting

Beavercreek, Ohio, United States, 05431

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

OnSite Clinical Solutions, LLC

Recruiting

Fort Mill, South Carolina, United States, 29715

Contacts

Kardigan Clinical Study Information Team

+1-877-310-5135 clinicaltrials@kardigan.bio

Chattanooga Research & Medicine CHARM

Recruiting

Chattanooga, Tennessee, United States, 37404

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

Laguna Clinical Research Associates

Recruiting

Laredo, Texas, United States, 78041

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

Tapia Internal Medicine Clinic

Recruiting

Paris, Texas, United States, 75460

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

Baylor Scott and White Research Institute - Temple

Recruiting

Temple, Texas, United States, 76502

Contacts

Kardigan Clinical Study Information Team

1-877-310-5135 clinicaltrials@kardigan.bio

More Information

Sponsor

Kardigan, Inc.

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Kardigan, Inc. on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.