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

Mild to Moderate Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423352
• Other study ID #: ALN-AGT01-006
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 7, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Alnylam Pharmaceuticals
• Contact: Alnylam Clinical Trial Information Line
• Phone: 1-877-ALNYLAM
• Email: clinicaltrials[@]alnylam.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Mild to Moderate Hypertension

Intervention

Drug:
• Zilebesiran
Zilebesiran administered by subcutaneous (SC) injection
• Placebo
Placebo administered by SC injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alnylam Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events (AEs)		Up to 12 months
Secondary	Percent Change from Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6		Baseline and Month 3 and Month 6
Secondary	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
Secondary	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
Secondary	Pharmacokinetics of Zilebesiran and its Metabolite assessed by Plasma Concentration		Predose and up to 3 days postdose