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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07553442

Enrollment

Registered

2026-04-28

Start date

2026-04-27

Completion date

2028-10-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

RNAi therapeutic, oligonucleotide, Reversir, Zilebesiran, ALN-AGT01

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.

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.

Interventions

DRUGALN-AGT01 RVR

ALN-AGT01 RVR will be administered subcutaneously (SC)

DRUGPlacebo

Placebo will be administered SC

DRUGZilebesiran

Zilebesiran will be administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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 /

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Contacts

CONTACTAlnylam Clinical Trial Information Line

clinicaltrials@alnylam.com1-877-ALNYLAM

STUDY_DIRECTORMedical Director

Alnylam Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026