NCT07553442

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
30mo left

Started Apr 2026

Typical duration for phase_2 hypertension

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Oct 2028

First Submitted

Initial submission to the registry

April 22, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

April 22, 2026

Last Update Submit

April 22, 2026

Conditions

Hypertension

Keywords

RNAi therapeuticoligonucleotideReversirZilebesiranALN-AGT01

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • 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

Study Arms (2)

ALN-AGT1 RVR

EXPERIMENTAL

Participants will be administered a single dose of zilebesiran followed by a single dose of ALN-AGT01 RVR.

Drug: ALN-AGT01 RVRDrug: Zilebesiran

Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose of zilebesiran followed by a single dose of placebo.

Drug: PlaceboDrug: Zilebesiran

Interventions

ALN-AGT01 RVRDRUG

ALN-AGT01 RVR will be administered subcutaneously (SC)

ALN-AGT1 RVR
PlaceboDRUG

Placebo will be administered SC

Placebo
ZilebesiranDRUG

Zilebesiran will be administered SC

ALN-AGT1 RVRPlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Trial Site

Lake Forest, California, 92630, United States

Location

Clinical Trial Site

Tampa, Florida, 33602, United States

Location

Clinical Trial Site

Savannah, Georgia, 31401, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Medical Director

    Alnylam Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Alnylam Clinical Trial Information Line

CONTACT

1-877-ALNYLAMclinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

CONTACT

1-877-256-9526clinicaltrials@alnylam.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2026

First Posted

April 28, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.

Locations

US(3)