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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

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

Clinical Trial Site
Tampa, Florida 33602

Clinical Trial Site
Savannah, Georgia 31401

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.