A Phase 2 interventional study of Tonlamarsen and Placebo in Hypertension, sponsored by Kardigan, Inc.. Completed at 39 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Kardigan, Inc. · Phase 2, Interventional, and Treatment
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).
Key Inclusion Criteria:
Key Exclusion Criteria:
1 dose of placebo and 5 doses of active drug will be administered by subcutaneous (SC) injection
Drug: Tonlamarsen
5 doses of placebo and 1 dose of active drug will be administered by subcutaneous (SC) injection
Drug: Placebo
Tonlamarsen will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
Placebo will be administered subcutaneously (SC) every 4 weeks during the randomized part of the study
To assess the effect of tonlamarsen on plasma angiotensinogen (AGT) levels
Percent Change from baseline (Week 0) in plasma angiotensinogen (AGT) levels to Week 20
Time frame: Week 20
To assess the systolic blood pressure-lowering efficacy of tonlamarsen
Change from baseline (Week 0) in mean office seated systolic blood pressure to Week 20
Time frame: Week 20
To assess the safety and tolerability of tonlamarsen
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.
Time frame: Week 28
To assess the efficacy of tonlamarsen in achieving office seated systolic blood pressure <130 mmHg
Proportion of participants with mean office seated systolic blood pressure \<130 mmHg at Week 20
Time frame: Week 20
To assess the systolic blood pressure-lowering efficacy of tonlamarsen
Change from baseline (Week 0) in mean self-assessed home systolic blood pressure through Week 20
Time frame: Week 20
To assess the effect of tonlamarsen on severe systolic blood pressure elevations
Proportion of participants with any daily average home systolic blood pressure ≥150 mmHg at Week 20
Time frame: Week 20
To assess the diastolic blood pressure-lowering efficacy of tonlamarsen
Change from baseline (Week 0) in mean office seated diastolic blood pressure to Week 20
Time frame: Week 20
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Kardigan, Inc.