RecruitingPhase 2NCT07511361

Study of Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital


Sponsor

Kardigan, Inc.

Enrollment

100 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently discharged from the hospital, after treatment for acute severe hypertension.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age 18 or older, body weight ≥ 50 kg
  • Recently discharged from the hospital to home within the past 3 days during which evaluation and/or treatment of acute severe hypertension (documented systolic blood pressure >180 mmHg and/or diastolic >110 mmHg) occurred, as measured by a healthcare provider within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
  • At Screening and Randomization visit, average systolic blood pressure > 145 mmHg
  • Presence of established cardiovascular or renal comorbidities

Exclusion Criteria7

  • Has known history of secondary hypertension
  • Any malignancy requiring treatment within 5 years
  • Has abnormal thyroid function with clinical significance
  • Recent hospitalization for stroke, type 1 myocardial infarction or coronary revascularization within 3 months prior to the first on-study visit
  • History of and/or obvious clinical signs or symptoms of cirrhosis or other significant liver disease
  • Alanine aminotransferase or aspartate aminotransferase >2 x upper limit of normal
  • Most recent hospitalization was for non-cardiovascular or non-renal conditions

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Interventions

DRUGTonlamarsen

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

DRUGPlacebo

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


Locations(4)

Western Nephrology and Metabolic Bone Disease, PC - Arvada

Arvada, Colorado, United States

Homestead Associates in Research

Homestead, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Chattanooga Research & Medicine CHARM

Chattanooga, Tennessee, United States

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NCT07511361


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