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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2025-07-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild to Moderate Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Zilebesiran

Participants will be administered a single dose of zilebesiran.

Group Type EXPERIMENTAL

Zilebesiran

Intervention Type DRUG

Zilebesiran administered by subcutaneous (SC) injection

Placebo

Participants will be administered a single dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered by SC injection

Interventions

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Zilebesiran

Zilebesiran administered by subcutaneous (SC) injection

Intervention Type DRUG

Placebo

Placebo administered by SC injection

Intervention Type DRUG

Other Intervention Names

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ALN-AGT01

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No