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

ConditionHypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlnylam Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Has known secondary hypertension or serum potassium more than 5 mmol/L

Has an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m²

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

93 Participants
are divided into 2 treatment groups
Group A: ALN-AGT1 RVRExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Part A: Percentage recovery from baseline in serum AGT

Time frame
Up to Day 4
2

Part B: Percentage recovery from baseline in mean seated office SBP

Time frame
At Day 4 and Day 7

Secondary outcomes

1

Both Parts: Frequency of Adverse Events (AEs)

Time frame
Up to 10 months
2

Part A: Percentage recovery from baseline in serum AGT

Time frame
Up to Day 7
3

Part B: Percentage recovery from baseline in serum AGT

Time frame
At Day 4 and Day 7
4

Part B: Change from baseline in mean seated office SBP

Time frame
At Day 4 and Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alnylam Pharmaceuticals

Lead sponsor

Hoffmann-La Roche

Collaborator

Source ClinicalTrials.gov
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