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

Kardigan, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Hypertension

Treatments: Drug: Tonlamarsen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06864104

TLA-201

Details and patient eligibility

About

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).

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 2 patient groups, including a placebo group

Tonlamarsen

Experimental group

Description:

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

Treatment:

Drug: Tonlamarsen

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo