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Recruiting NCT07553442

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

Phase II Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALN-AGT01 RVR, Placebo, Zilebesiran.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Single Dose Study of the Efficacy, Pharmacodynamics, and Safety of ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran

Overview

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.

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.

Interventions

  • Drug ALN-AGT01 RVR
    ALN-AGT01 RVR will be administered subcutaneously (SC)
  • Drug Placebo
    Placebo will be administered SC
  • Drug Zilebesiran
    Zilebesiran will be administered SC

Primary outcome measures

  • Part A: Percentage recovery from baseline in serum AGT [Time frame: Up to Day 4]
  • Part B: Percentage recovery from baseline in mean seated office SBP [Time frame: At Day 4 and Day 7]
Secondary outcome measures (4)
  • Both Parts: Frequency of Adverse Events (AEs) [Time frame: Up to 10 months]
  • Part A: Percentage recovery from baseline in serum AGT [Time frame: Up to Day 7]
  • Part B: Percentage recovery from baseline in serum AGT [Time frame: At Day 4 and Day 7]
  • Part B: Change from baseline in mean seated office SBP [Time frame: At Day 4 and Day 7]

Eligibility criteria

Part A: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Clinical Trial Site — Lake Forest
  • Clinical Trial Site — Tampa
  • Clinical Trial Site — Savannah

Identifiers

NCT: NCT07553442 · ALN-AGT01 RVR-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗