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Completed

NCT Number: NCT06423352

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

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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Key information

Conditions

Mild to Moderate Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Trial Site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Zilebesiran

Drug

Zilebesiran administered by subcutaneous (SC) injection

Other names: ALN-AGT01

Placebo

Drug

Placebo administered by SC injection

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 12 months

    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.

Secondary outcomes

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

    Time frame: Baseline and Month 3 and Month 6

  2. 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

  3. 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

  4. Maximum Plasma Concentration (Cmax) of Zilebesiran and Its Metabolite

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

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

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

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

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

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

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

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

  7. Area Under the Curve (AUClast) of Zilebesiran and Its Metabolite

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

    AUClast is the AUC from the time of dosing to the last measurable concentration of the drug.

  8. Pooled Urine PK (fe) of Zilebesiran and Its Metabolite

    Time frame: Predose and 2 to 6, 6 to 12, and 12 to24 hours post-dose.

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 21, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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