RecruitingRecruiting
Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
NCT07511361 · Kardigan, Inc.
In plain English
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Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Part Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension
About this study
The Sponsor is studying an investigational medication called tonlamarsen to determine if it can help people recently treated for acute severe hypertension (hypertensive emergency and urgency).
The purpose of this study is to evaluate how well tonlamarsen works compared to a placebo and to see how safe it is for people following a recent episode of acute severe hypertension. Tonlamarsen is designed to block the body's liver from making a protein called angiotensinogen (AGT), which plays a key role in controlling blood pressure.
The main goals of the study are:
* To assess the effect of tonlamarsen on the amount of AGT in blood over time
* To assess the effect of tonlamarsen on blood pressure
* To evaluate the safety and tolerability of tonlamarsen
Participants will:
* Receive monthly doses of tonlamarsen for approximately 3 months
* Visit the clinic about 7 times, including initial evaluation, checkups, tests, and follow-up
Eligibility criteria
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) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization
* At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg
* Presence of established cardiovascular or renal disease
Key Exclusion Criteria:
* Has known history of secondary hypertension
* Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated)
* Has abnormal thyroid function with clinical significance
* Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening
* 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
Study design
Enrollment target: 140 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-06-23
Estimated completion: 2027-02
Last updated: 2026-09-02
Interventions
Drug: TonlamarsenDrug: Placebo
Primary outcomes
- • 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)
- • Part B: To assess the pharmacodynamic (PD) effect of tonlamarsen on plasma AGT levels (Week 4)
Sponsor
Kardigan, Inc. · industry
Contacts & investigators
ContactKardigan Clinical Study Information Team · contact · clinicaltrials@kardigan.bio · +1-877-310-5135
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