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Not recruiting

Phase 2

TonlamarsenA Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension

Sponsor:

Kardigan, Inc.

Code:

NCT06864104

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

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, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (BP).

Conditions

Hypertension

Study ID

NCT06864104

Start date

Apr 10, 2025

Status verified date

Feb, 2025

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Age 18 to 80, body weight ≥ 50 kg
Has uncontrolled hypertension while receiving between 2 and 5 antihypertensive medications prescribed for hypertension
Has mean office seated systolic blood pressure > 135 to ≤ 170 mmHg

Key Exclusion Criteria:

Has known history of secondary hypertension
Has documented history of poor adherence to antihypertensive medication
Has unstable/underlying known cardiovascular disease
Has abnormal thyroid function with clinical significance

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tonlamarsen

1 dose of placebo and up to 13 doses of active drug will be administered by subcutaneous (SC) injection

placebo comparator: Placebo

5 doses of placebo and up to 9 doses of active drug will be administered by subcutaneous (SC) injection

Interventions

Tonlamarsen

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

Placebo

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

Primary outcome measure

Change from baseline (Week 0) to Week 20 in mean office seated systolic blood pressure. [ Time Frame: Week 20 ]

Central Contacts and Locations

Central contacts

Kardigan Clinical Study Information Team

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

Locations

Pinnacle Research Group

Recruiting

Anniston, Alabama, United States, 36207

Contacts

Kardigan Clinical Study Information Team

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

Elite Clinical Studies

Recruiting

Phoenix, Arizona, United States, 85018

Contacts

Kardigan Clinical Study Information Team

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

Clinical Trials Research

Recruiting

Lincoln, California, United States, 95648

Contacts

Kardigan Clinical Study Information Team

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

American Institute of Research

Recruiting

Los Angeles, California, United States, 90017

Contacts

Kardigan Clinical Study Information Team

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

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

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

Agile Clinical Research Trials, LLC

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Kardigan Clinical Study Information Team

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

Clinical Investigation Specialists, Inc.

Recruiting

Gurnee, Illinois, United States, 60031

Contacts

Kardigan Clinical Study Information Team

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

DelRicht Clinical Research - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Kardigan Clinical Study Information Team

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

Chear Center LLC

Recruiting

Bronx, New York, United States, 10455

Contacts

Kardigan Clinical Study Information Team

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

Health Concepts

Recruiting

Rapid City, South Dakota, United States, 57702

Contacts

Kardigan Clinical Study Information Team

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

Holston Medical Group

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Kardigan Clinical Study Information Team

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

Central Texas Clinical Research

Recruiting

Austin, Texas, United States, 78705

Contacts

Kardigan Clinical Study Information Team

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

Advanced Medical Trials Georgetown, LLC

Recruiting

Georgetown, Texas, United States, 78628

Contacts

Kardigan Clinical Study Information Team

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

Juno Research, LLC

Recruiting

Houston, Texas, United States, 77040

Contacts

Kardigan Clinical Study Information Team

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

Radiance Clinical Research

Recruiting

Lampasas, Texas, United States, 76550

Contacts

Kardigan Clinical Study Information Team

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

Synergy Groups Medical

Recruiting

Missouri City, Texas, United States, 77459

Contacts

Kardigan Clinical Study Information Team

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

North Hills Medical Research Inc.

Recruiting

North Richland Hills, Texas, United States, 76180

Contacts

Kardigan Clinical Study Information Team

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

Sun Research Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Kardigan Clinical Study Information Team

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

Manassas Clinical Research Center

Recruiting

Manassas, Virginia, United States, 20110

Contacts

Kardigan Clinical Study Information Team

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

York Clinical Research LLC

Recruiting

Norfolk, Virginia, United States, 23504

Contacts

Kardigan Clinical Study Information Team

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

More Information

Sponsor

Kardigan, Inc.

Last update posted

May 6, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Kardigan, Inc. on 2025-05-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.