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

NCT07553442 · Alnylam Pharmaceuticals
In plain English

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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
About this study
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.
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
Study design
Enrollment target: 93 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-04-27
Estimated completion: 2028-10-01
Last updated: 2026-05-14
Interventions
Drug: ALN-AGT01 RVRDrug: PlaceboDrug: Zilebesiran
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)
Sponsor
Alnylam Pharmaceuticals · industry
With: Hoffmann-La Roche
Contacts & investigators
ContactAlnylam Clinical Trial Information Line · contact · clinicaltrials@alnylam.com · 1-877-ALNYLAM
ContactAlnylam Clinical Trial Information Line · contact · clinicaltrials@alnylam.com · 1-877-256-9526
InvestigatorMedical Director · study_director, Alnylam Pharmaceuticals
All locations (3)
Clinical Trial SiteRecruiting
Lake Forest, California, United States
Clinical Trial SiteRecruiting
Tampa, Florida, United States
Clinical Trial SiteRecruiting
Savannah, Georgia, United States
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran · TrialPath