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

Phase 1

Active, not recruiting

• Conditions: Mild to Moderate Hypertension
• Interventions: Drug: Placebo; Drug: Zilebesiran

• Registration Number: NCT06423352
• Lead Sponsor: Alnylam Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-21
• Study Start: 2024-06-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will be administered a single dose of placebo.
Zilebesiran	Zilebesiran	Participants will be administered a single dose of zilebesiran.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs)	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline at Month 3 and Month 6 in SBP and DBP Assessed by Office Blood Pressure	Baseline and Month 3 and Month 6
Percent Change from Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6	Baseline and Month 3 and Month 6
Pharmacokinetics of Zilebesiran and its Metabolite assessed by Plasma Concentration	Predose and up to 3 days postdose
Change from Baseline at Month 3 and Month 6 in 24-hour Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)	Baseline and Month 3 and Month 6

Trial Locations

Locations (1)

Clinical Trial Site; 🇯🇵 Tokyo, Japan