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

Launched by ALNYLAM PHARMACEUTICALS · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called zilebesiran for Japanese patients who have mild to moderate high blood pressure, also known as hypertension. The main goals of the trial are to see if zilebesiran is safe, how well it works, and how the body processes it. It is currently active but not recruiting new participants.

To be eligible for this study, participants must be of Japanese descent and have a specific range of blood pressure levels, which means their average blood pressure readings should be over 130 but not more than 165 mmHg. They should also have a 24-hour average blood pressure of at least 130 mmHg without taking any blood pressure medications. Participants can expect to undergo some tests to monitor their health and blood pressure during the trial. It’s important to note that certain medical conditions or recent treatments may exclude someone from participating, so potential candidates should discuss their health history with their doctor.

Gender

ALL

Eligibility criteria

• 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)