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
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
• 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
Locations
United States
California
Clinical Trial Site
RECRUITING
Lake Forest
Florida
Clinical Trial Site
RECRUITING
Tampa
Georgia
Clinical Trial Site
RECRUITING
Savannah
Contact Information
Primary
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 93
Treatments
Experimental: ALN-AGT1 RVR
Participants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR.
Placebo_comparator: Placebo
Participants will be administered a single dose of zilebesiran followed by a single dose of placebo.
Related Therapeutic Areas
Sponsors
Collaborators: Hoffmann-La Roche
Leads: Alnylam Pharmaceuticals