A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran

Purpose

The purpose of this study is to evaluate the efficacy, pharmacodynamics (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran.

Condition

  • Hypertension

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Is an adult participant with a mean seated office systolic blood pressure (SBP) of at least 130 mmHg and no more than than 170 mmHg - Either not taking antihypertensive medication or on stable therapy with up to 2 antihypertensive medications Part B: Inclusion Criteria - Is an adult participant with a mean seated office SBP of at least 140 mmHg and no more than 170 mmHg - Has discontinued all prior antihypertensive medication other than a calcium channel blocker (CCB) and/or thiazide/thiazide-like diuretic (if taking) for at least 3 weeks Both Parts:

Exclusion Criteria

  • Has known secondary hypertension or serum potassium more than 5 mmol/L - Has an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m^2 Note: other protocol defined inclusion / exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ALN-AGT1 RVR 		Participants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR.
  • Drug: ALN-AGT01 RVR
    ALN-AGT01 RVR will be administered subcutaneously (SC)
  • Drug: Zilebesiran
    Zilebesiran will be administered SC
Placebo Comparator
Placebo 		Participants will be administered a single dose of zilebesiran followed by a single dose of placebo.
  • Drug: Placebo
    Placebo will be administered SC
  • Drug: Zilebesiran
    Zilebesiran will be administered SC

Recruiting Locations

Clinical Trial Site
Lake Forest, California 92630

More Details

Status
Recruiting
Sponsor
Alnylam Pharmaceuticals

Study Contact

Alnylam Clinical Trial Information Line
1-877-ALNYLAM
clinicaltrials@alnylam.com

Detailed Description

This study will be conducted in 2 parts: - Part A: Single dose (SD), dose-ranging part in adults with mild to moderate hypertension. - Part B: SD in adults with mild to moderate hypertension.