A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension

Alnylam Pharmaceuticals36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Mild to Moderate Hypertension

Interventions

ZilebesiranDRUG

Zilebesiran administered by subcutaneous (SC) injection

PlaceboDRUG

Placebo administered by SC injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Time frame: Up to 12 months

Secondary Outcomes

Percent Change From Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6

Time frame: Baseline and Month 3 and Month 6

Change From Baseline at Month 3 and Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM

Time frame: Baseline and Month 3 and Month 6

Change From Baseline at Month 3 and Month 6 in SBP and DBP Assessed by OBP

Time frame: Baseline and Month 3 and Month 6

Maximum Plasma Concentration (Cmax) of Zilebesiran and Its Metabolite

Cmax is the highest concentration of zilebesiran in the plasma and metabolite after a dose is given.

Time frame: Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.

Time to Maximum Plasma Concentration (Tmax) of Zilebesiran and Its Metabolite

Tmax is the time it takes for zilebesiran to reach the Cmax after administration.

Time frame: Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.

Elimination Half-life (t1/2) of Zilebesiran and Its Metabolite

t½ is the time it takes for the concentration of the drug in the plasma to be reduced by 50%.

Time frame: Predose and 30 minutes, 1, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose.

Data from ClinicalTrials.gov

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