Tonlamarsen for High Blood Pressure

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Kardigan, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults aged 18 to 80 with uncontrolled hypertension, despite taking 2-5 blood pressure medications. Participants must have a seated systolic BP >135 but ≤170 mmHg and weigh at least 50 kg. It's not for those with unstable heart disease, secondary hypertension, poor medication adherence, or significant thyroid issues.

Inclusion Criteria

Has mean office seated systolic blood pressure > 135 to ≤ 170 mmHg

My high blood pressure is not controlled despite taking 2-5 medications for it.

I am between 18 and 80 years old and weigh at least 50 kg.

Exclusion Criteria

I have a heart condition that is not well-controlled.

I have been diagnosed with high blood pressure caused by another condition.

Has documented history of poor adherence to antihypertensive medication

+1 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly subcutaneous administration of Tonlamarsen or placebo

13 months

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests Tonlamarsen's ability to lower blood pressure in adults who haven't reached their target BP on current meds. Participants will either receive Tonlamarsen or a placebo without knowing which one they're getting.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TonlamarsenExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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