MedTrace Logo

A Study to Evaluate ALN-AGT01 in Patients With Hypertension

NCT03934307 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-01-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ALN-AGT01

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

DRUG

ALN-AGT01-Matching Placebo

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

DRUG

Irbesartan

Irbesartan will be administered orally.

DRUG

Irbesartan-Matching Placebo

Irbesartan-matching placebo will be administered orally.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-04-20
Completion
2023-01-04

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03934307 on ClinicalTrials.gov