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

NCT06423352 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ALN-AGT01-006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Mild to Moderate Hypertension

Keywords

High blood pressure; Hypertension; Hypertensive; siRNA; Angiotensinogen; AGT

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (8)

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

  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

  Baseline and Month 3 and Month 6

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

  Baseline and Month 3 and Month 6

• Maximum Plasma Concentration (Cmax) of Zilebesiran and Its Metabolite

  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

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

Study Arms (2)

Zilebesiran

EXPERIMENTAL

Participants will be administered a single dose of zilebesiran.

Drug: Zilebesiran

Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose of placebo.

Drug: Placebo

Interventions

Zilebesiran DRUG

Zilebesiran administered by subcutaneous (SC) injection

Also known as: ALN-AGT01

Zilebesiran

Placebo DRUG

Placebo administered by SC injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alnylam Pharmaceuticals: lead

Study Sites (3)

Clinical Trial Site

Fukuoka, Japan

Location

Clinical Trial Site

Osaka, Japan

Location

Clinical Trial Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Alnylam Pharmaceuticals Inc.

clinicaltrials@alnylam.com

866-330-0326

Study Officials

• Medical Director

  Alnylam Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: June 5, 2024
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)