NCT07553442 · Alnylam Pharmaceuticals
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
What this study is about
The purpose of this study is to evaluate the effectiveness, how the drug affects the body (PD), and safety of ALN-AGT01 RVR in participants with mild to moderate hypertension pretreated with zilebesiran.
View original scientific description
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.
Interventions
DRUG
ALN-AGT01 RVR
ALN-AGT01 RVR will be administered subcutaneously (SC)
DRUG
Placebo
Placebo will be administered SC
DRUG
Zilebesiran
Zilebesiran will be administered SC
Primary outcome measures
Part A: Percentage recovery from baseline in serum AGT
Time frame: Up to Day 4
Part B: Percentage recovery from baseline in mean seated office SBP
Time frame: At Day 4 and Day 7
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Lake Forest, California
- Tampa, Florida
- Savannah, Georgia
Collaborators
Hoffmann-La Roche
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations