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

NCT07553442 — Phase 2, Recruiting, 93 participants, Alnylam Pharmaceuticals

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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

Registry	NCT07553442
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	93 (Estimated)
Sponsor	Alnylam Pharmaceuticals (Industry); collaborators: Hoffmann-La Roche
Conditions	Hypertension
Interventions	ALN-AGT01 RVR, Placebo, Zilebesiran (Drug)
Dates	start 2026-04-27, primary completion 2028-04-01 (estimated), completion 2028-10-01 (estimated), first posted 2026-04-28, last updated 2026-10-08
Locations	3 sites in United States

-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.

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+Detailed description

This study will be conducted in 2 parts:

* Part A: Single dose (SD), dose-ranging part in adults with mild to moderate hypertension.
* Part B: SD in adults with mild to moderate hypertension.

+Arms and interventions

Arm	Type	Interventions	Description
ALN-AGT1 RVR	Experimental	Drug: ALN-AGT01 RVR; Drug: Zilebesiran	Participants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR.
Placebo	Placebo comparator	Drug: Placebo; Drug: Zilebesiran	Participants will be administered a single dose of zilebesiran followed by a single dose of placebo.

ALN-AGT01 RVR (Drug): ALN-AGT01 RVR will be administered subcutaneously (SC)
Placebo (Drug): Placebo will be administered SC
Zilebesiran (Drug): Zilebesiran will be administered SC

+Outcome measures

Primary outcomes

Part A: Percentage recovery from baseline in serum AGT [Up to Day 4]
Part B: Percentage recovery from baseline in mean seated office SBP [At Day 4 and Day 7]

Secondary outcomes

Both Parts: Frequency of Adverse Events (AEs) [Up to 10 months]
Part A: Percentage recovery from baseline in serum AGT [Up to Day 7]
Part B: Percentage recovery from baseline in serum AGT [At Day 4 and Day 7]
Part B: Change from baseline in mean seated office SBP [At Day 4 and Day 7]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (3)

Facility	City	Country	Status
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

+Investigators

Medical Director, Study director, Alnylam Pharmaceuticals

My Notes

Public

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