A Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Multicenter Study to Evaluate the Efficacy and Safety of ALN-AGT01 in Patients With Mild-to-Moderate Hypertension (KARDIA-1)

  • End date
    Dec 25, 2024
  • participants needed
  • sponsor
    Alnylam Pharmaceuticals
Updated on 25 October 2022
systolic blood pressure
antihypertensive drugs


The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.


Participants will receive ALN-AGT01 or placebo for the first 6 months of the 12-month double-blind (DB) treatment period. Participants randomized to placebo will be re-randomized at Month 6 to 1 of the 4 initial ALN-AGT01 regimens until the end of the 12-month DB treatment period. Participants randomized to ALN-AGT01 regimens will remain on their originally assigned regimens through remainder of the study.

Condition Hypertension
Treatment Placebo, ALN-AGT01
Clinical Study IdentifierNCT04936035
SponsorAlnylam Pharmaceuticals
Last Modified on25 October 2022


Yes No Not Sure

Inclusion Criteria

Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication

Exclusion Criteria

Secondary hypertension, orthostatic hypotension
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN)
Elevated potassium >5 mEq/L
Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m^2
Received an investigational agent within the last 30 days
Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus
History of any cardiovascular event within 6 months prior to randomization
History of intolerance to SC injection(s)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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