A person-friendly look at ALN-AGT01 RVR in adults with mild to moderate high blood pressure who had prior zilebesiran
Official title: 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
Run by Alnylam Pharmaceuticals · NCT07553442 · Data updated 2026-11-12
This study tests whether ALN-AGT01 RVR can help adults with mild to moderate hypertension who previously used zilebesiran.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 3 sites (Lake Forest, California and 2 other locations) |
| Status | Recruiting |
| Started | April 27, 2026 |
| Main results expected | April 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07553442 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with mild to moderate hypertension, either not on antihypertensives or on up to two agents, and who meet specific SBP ranges and health criteria.
✕Probably not a fit
Participants with uncontrolled secondary hypertension, severe kidney impairment, or high potassium may not benefit and could be excluded from the trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial is designed to test different single-dose levels of ALN-AGT01 RVR, with and without prior zilebesiran exposure, in adults with mild to moderate hypertension. It has two parts: Part A examines dose ranges in participants on stable or no antihypertensive therapy, and Part B repeats a single-dose evaluation after stopping most prior antihypertensives. The study also includes placebo and zilebesiran as comparators to understand pharmacodynamics, efficacy on blood pressure, and safety. Enrollment is limited to adults within specified blood pressure ranges and without certain kidney or electrolyte conditions. The trial is conducted at sites in California, Florida, and Georgia under Alnylam Pharmaceuticals with Roche collaboration.
Why it matters
Potential benefit: If successful, participants may experience better blood pressure responses with a well-tolerated single-dose regimen.
How similar studies have gone: Previous RNAi-based approaches have shown potential in blood pressure reduction; this study explores a novel combination and patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Part A: 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 it's running
-
Clinical Trial Site
Lake Forest, California, United States Recruiting -
Clinical Trial Site
Tampa, Florida, United States Active not recruiting -
Clinical Trial Site
Savannah, Georgia, United States Active not recruiting
Study contacts
- Study coordinator: Alnylam Clinical Trial Information Line
- Email: clinicaltrials@alnylam.com
- Phone: 1-877-ALNYLAM
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.