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Completed

NCT Number: NCT03934307

A Study to Evaluate ALN-AGT01 in Patients With Hypertension

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of subcutaneous (SC) ALN-AGT01 (zilebesiran) in participants with hypertension. The study will be conducted in 4 parts: Part A will be a single ascending dose (SAD) phase in hypertensive participants, Part B will be a single dose (SD) phase in hypertensive participants with controlled salt intake, Part D will be a MD phase in hypertensive participants who are obese, and Part E will be an open-label SD phase with co-administration of irbesartan in hypertensive patients.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site, Edinburgh, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has mild to moderate hypertension with mean sitting systolic blood pressure (SBP) of >130 and ≤165 mmHg without hypertensive medication for Parts A, B and D, and >135 and ≤165 mmHg without hypertensive medication for Part E
  • Parts A and B: Has body mass index (BMI) ≥18 and ≤35 kg/m^2; Part D: Has BMI >35 and ≤50 kg/m^2; Part E: Has BMI ≥18 kg/m^2 and ≤50 kg/m^2
  • Has a normal 12-lead electrocardiogram (ECG)
  • Is a nonsmoker

Exclusion criteria

  • Has secondary hypertension
  • Has orthostatic hypotension
  • Has estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m^2
  • Recently received an investigational agent
  • Has diabetes mellitus
  • Has history of any cardiovascular event
  • Has history of intolerance to SC injection(s)

Treatment and study plan

ALN-AGT01

Drug

ALN-AGT01 will be administered by subcutaneous (SC) injection.

Other names: Zilebesiran

ALN-AGT01-Matching Placebo

Drug

Normal saline (0.9% NaCl) matching volume of ALN-AGT01 doses will be administered SC.

Irbesartan

Drug

Irbesartan will be administered orally.

Irbesartan-Matching Placebo

Drug

Irbesartan-matching placebo will be administered orally.

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Parts A, B and E: each up to approximately 12 months; Part D: up to approximately 18 months

Secondary outcomes

  1. Change from Baseline in Blood Angiotensinogen (AGT) Level

    Time frame: Parts A, B and E: each up to approximately 12 months; Part D: up to approximately 18 months

  2. Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 and of Potential Metabolites

    Time frame: Parts A, B and E: Up to Day 15; Part D: Up to Day 99

  3. Area Under the Concentration-time Curve (AUC) of ALN-AGT01 and of Potential Metabolites

    Time frame: Parts A, B and E: Up to Day 15; Part D: Up to Day 99

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Dose and Active Comparator-Controlled Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-AGT01 in Patients With Hypertension

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
May 1, 2019
Registry last updated
Jan 17, 2023

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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