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

Alnylam Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Mild to Moderate Hypertension

Treatments: Drug: Placebo; Drug: Zilebesiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT06423352

ALN-AGT01-006

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Zilebesiran

Experimental group

Description:

Participants will be administered a single dose of zilebesiran.

Treatment:

Drug: Zilebesiran

Placebo

Placebo Comparator group

Description:

Participants will be administered a single dose of placebo.

Treatment:

Drug: Placebo