NCT06423352CompletedPhase 1/2
A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
A Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 15 May 2024
- Start date
- 5 Jun 2024
- Primary completion date
- 17 Jul 2025
- Lead sponsor
- Alnylam Pharmaceuticals
- Diseases
- High blood pressure
- NCT number
- NCT06423352
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 36
- From 5 Jun 2024 to the primary completion date, 17 Jul 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received an investigational agent within the last 30 days
Other illness
- Has secondary hypertension, symptomatic orthostatic hypotension
- Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus
- Has history of intolerance to SC injection(s)
Lab values
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
- Has elevated serum potassium \>5 mmol/L
- Has estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m\^2
Who the study is looking for
- Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin
- Has mean systolic office blood pressure (SBP) of \>130 and \<=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication
- Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.