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Tonlamarsen

Phase 2

Hypertension | RNA therapy | Cardiovascular |Kardigan, Inc.|Trials Updated: Oct 15, 2026

Tonlamarsen development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Mar 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment346

FDA Designations

No designations recorded

Tonlamarsen clinical trials

Tonlamarsen · 2 trials · 4 indications

Phase 2 2
NCT07511361Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe HypertensionHypertension
RECRUITING140 Analytics
NCT06864104A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension (KARDINAL)Hypertension
COMPLETED206 Analytics
PHASE2RECRUITING
Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
HypertensionUnlock trial analytics
PHASE2COMPLETED
A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension (KARDINAL)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: To assess variability in clinical and biomarker measures to inform Part B sample-size estimation and study-design assumptions
Baseline through Week 12

* Change from baseline in plasma angiotensinogen (AGT) levels and systolic blood pressure * Variability in plasma AGT levels and systolic blood pressure

Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels
Week 4

Percent change in plasma AGT levels from Baseline to Week 4

To assess the effect of tonlamarsen on plasma angiotensinogen (AGT) levels
Week 20

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

To assess the systolic blood pressure-lowering efficacy of tonlamarsen
Week 20

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

Secondary Endpoints

Part A: To assess the safety and tolerability of tonlamarsen compared with placebo
Week 36
Part A: To assess the feasibility of using AGT levels and systolic blood pressure as efficacy endpoints
Baseline through Week 12
Part B: To assess the safety and tolerability of tonlamarsen compared with placebo
Week 36
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TonlamarsenEXPERIMENTAL3 doses active drug will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)
PlaceboPLACEBO_COMPARATOR3 doses of placebo will be administered by subcutaneous (under the skin) injection (one dose every 4 weeks)

Interventions

NameTypeDescription
TonlamarsenDRUGTonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
PlaceboDRUGPlacebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Key Inclusion Criteria: * Age 18 or older, body weight ≥ 50 kg with BMI ≤45.0 kg/m2 * Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and/or treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)...

Countries:United States
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