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NCT Number: NCT07553442

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trial Site, Lake Forest, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALN-AGT01 RVR

Drug

ALN-AGT01 RVR will be administered subcutaneously (SC)

Placebo

Drug

Placebo will be administered SC

Zilebesiran

Drug

Zilebesiran will be administered SC

Primary outcomes

  1. Part A: Percentage recovery from baseline in serum AGT

    Time frame: Up to Day 4

  2. Part B: Percentage recovery from baseline in mean seated office SBP

    Time frame: At Day 4 and Day 7

Secondary outcomes

  1. Both Parts: Frequency of Adverse Events (AEs)

    Time frame: Up to 10 months

  2. Part A: Percentage recovery from baseline in serum AGT

    Time frame: Up to Day 7

  3. Part B: Percentage recovery from baseline in serum AGT

    Time frame: At Day 4 and Day 7

  4. Part B: Change from baseline in mean seated office SBP

    Time frame: At Day 4 and Day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Alnylam Clinical Trial Information Line

CONTACT

[email protected]

1-877-ALNYLAM

Alnylam Clinical Trial Information Line

CONTACT

[email protected]

1-877-256-9526

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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