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Completed

NCT Number: NCT06864104

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

The purpose of this study is to evaluate the blood pressure (BP)-lowering efficacy of tonlamarsen in adult participants who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (BP).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tonlamarsen

Drug

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

Placebo

Drug

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

Primary outcomes

  1. To assess the effect of tonlamarsen on plasma angiotensinogen (AGT) levels

    Time frame: Week 20

    Percent Change from baseline (Week 0) in plasma angiotensinogen (AGT) levels to Week 20

  2. To assess the systolic blood pressure-lowering efficacy of tonlamarsen

    Time frame: Week 20

    Change from baseline (Week 0) in mean office seated systolic blood pressure to Week 20

Secondary outcomes

  1. To assess the safety and tolerability of tonlamarsen

    Time frame: Week 28

    Incidence and severity of treatment emergent adverse events (TEAEs). Incidence of clinically significant abnormalities in laboratory assessments, ECGs and vital signs. Incidence of: (1) Hyperkalemia, defined as serum potassium >5.5 mmol/L. (2) Hypotension, defined as systolic blood pressure <90 mmHg, or systolic blood pressure <100 mmHg and symptomatic and/or requiring clinical intervention. (3) Renal dysfunction, defined as a decrease of eGFR >30% from baseline value. (4) Increased proteinuria, defined as UPCR >0.5 mg/mg from baseline value.

  2. To assess the efficacy of tonlamarsen in achieving office seated systolic blood pressure <130 mmHg

    Time frame: Week 20

    Proportion of participants with mean office seated systolic blood pressure <130 mmHg at Week 20

  3. To assess the systolic blood pressure-lowering efficacy of tonlamarsen

    Time frame: Week 20

    Change from baseline (Week 0) in mean self-assessed home systolic blood pressure through Week 20

  4. To assess the effect of tonlamarsen on severe systolic blood pressure elevations

    Time frame: Week 20

    Proportion of participants with any daily average home systolic blood pressure ≥150 mmHg at Week 20

  5. To assess the diastolic blood pressure-lowering efficacy of tonlamarsen

    Time frame: Week 20

    Change from baseline (Week 0) in mean office seated diastolic blood pressure to Week 20

Sponsors and collaborators

Lead sponsor

Kardigan, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Monthly Subcutaneous Administration of Tonlamarsen in Participants With Uncontrolled Hypertension (KARDINAL)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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