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Recruiting Phase 2 NCT07553442

NCT07553442 A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran

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Clinical Trial Summary
NCT ID NCT07553442
Status Recruiting
Phase Phase 2
Sponsor Alnylam Pharmaceuticals
Condition Hypertension
Study Type INTERVENTIONAL
Enrollment 93 participants
Start Date 2026-04-27
Primary Completion 2028-04-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
ALN-AGT01 RVRPlaceboZilebesiran

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 93 participants in total. It began in 2026-04-27 with a primary completion date of 2028-04-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Alnylam Clinical Trial Information Line

✉ clinicaltrials@alnylam.com

📞 1-877-ALNYLAM

Principal Investigator

Medical Director

STUDY DIRECTOR

Alnylam Pharmaceuticals

Frequently Asked Questions

Who can join the NCT07553442 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07553442 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT07553442 currently recruiting?

Yes, NCT07553442 is actively recruiting participants. Contact the research team at clinicaltrials@alnylam.com for enrollment information.

Where is the NCT07553442 trial being conducted?

This trial is being conducted at Lake Forest, United States, Tampa, United States, Savannah, United States.

Who is sponsoring the NCT07553442 clinical trial?

NCT07553442 is sponsored by Alnylam Pharmaceuticals. The principal investigator is Medical Director at Alnylam Pharmaceuticals. The trial plans to enroll 93 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology