Recruiting
Phase 2

ALN-AGT01 with Zilebesiran

Sponsor:

Alnylam Pharmaceuticals

Code:

NCT07553442

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALN-AGT01 RVR

Placebo

Zilebesiran

Study Details

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.

Conditions

Hypertension

Study ID

NCT07553442

Start date

Apr 27, 2026

Status verified date

Aug, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

93 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-AGT1 RVR

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

placebo comparator: Placebo

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

Interventions

ALN-AGT01 RVR

ALN-AGT01 RVR will be administered subcutaneously (SC)

Placebo

Placebo will be administered SC

Zilebesiran

Zilebesiran will be administered SC

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Alnylam Clinical Trial Information Line

1-877-ALNYLAMclinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

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

Locations

Clinical Trial Site

Recruiting

Lake Forest, California, United States, 92630

More Information

Sponsor

Alnylam Pharmaceuticals

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alnylam Pharmaceuticals on 2026-08-14.