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A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT06423352•Alnylam Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•Has secondary hypertension, symptomatic orthostatic hypotension
•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
•Has received an investigational agent within the last 30 days
•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)

Locations (3)

Clinical Trial Site

Fukuoka, Japan

Clinical Trial Site

Osaka, Japan

Clinical Trial Site

Tokyo, Japan

Key Dates

Start Date

June 5, 2024

Primary Completion Date

July 17, 2025

Completion Date

July 17, 2025

Last Updated

August 29, 2025

Enrollment

ACTUAL participants

Conditions

Mild to Moderate Hypertension

Interventions

Zilebesiran

DRUG

Placebo

DRUG