A Study to Evaluate ALN-AGT01 in Patients With Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-01-04

Brief Summary

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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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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: SAD: ALN-AGT01

Participants will be administered a single dose of ALN-AGT01.

Group Type EXPERIMENTAL

ALN-AGT01

Intervention Type DRUG

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

Part A: SAD: ALN-AGT01-Matching Placebo

Participants will be administered a single dose of ALN-AGT01-matching placebo.

Group Type PLACEBO_COMPARATOR

ALN-AGT01-Matching Placebo

Intervention Type DRUG

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

Part B: SD: ALN-AGT01

Participants with controlled salt intake will be administered a single dose of ALN-AGT01.

Group Type EXPERIMENTAL

ALN-AGT01

Intervention Type DRUG

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

Part B: SD: ALN-AGT01-Matching Placebo

Participants with controlled salt intake will be administered a single dose of ALN-AGT01-matching placebo.

Group Type PLACEBO_COMPARATOR

ALN-AGT01-Matching Placebo

Intervention Type DRUG

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

Part D: MD: ALN-AGT01 + Irbesartan-Matching Placebo

Participants, who are obese, will be administered multiple doses of ALN-AGT01 and irbesartan-matching placebo.

Group Type EXPERIMENTAL

ALN-AGT01

Intervention Type DRUG

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

Irbesartan-Matching Placebo

Intervention Type DRUG

Irbesartan-matching placebo will be administered orally.

Part D: MD: ALN-AGT01-Matching Placebo + Irbesartan

Participants, who are obese, will be administered multiple doses of ALN-AGT01-matching placebo and irbesartan.

Group Type ACTIVE_COMPARATOR

ALN-AGT01-Matching Placebo

Intervention Type DRUG

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

Irbesartan

Intervention Type DRUG

Irbesartan will be administered orally.

Part E: Open Label: ALN-AGT01 + Irbesartan

Participants will be administered a single dose of ALN-AGT01 and multiple doses of irbesartan.

Group Type EXPERIMENTAL

ALN-AGT01

Intervention Type DRUG

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

Irbesartan

Intervention Type DRUG

Irbesartan will be administered orally.

Interventions

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ALN-AGT01

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

Intervention Type DRUG

ALN-AGT01-Matching Placebo

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

Intervention Type DRUG

Irbesartan

Irbesartan will be administered orally.

Intervention Type DRUG

Irbesartan-Matching Placebo

Irbesartan-matching placebo will be administered orally.

Intervention Type DRUG

Other Intervention Names

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Zilebesiran

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No