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A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension (KARDIA-1) (KARDIA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04936035
Recruitment Status : Active, not recruiting
First Posted : June 23, 2021
Last Update Posted : November 15, 2023
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Placebo Drug: ALN-AGT01 Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 7, 2021
Actual Primary Completion Date : April 4, 2023
Estimated Study Completion Date : December 31, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ALN-AGT01 Dose Regimen 1
Multiple doses of ALN-AGT01 administered by subcutaneous (SC) injection during the 12-month DB treatment period.
 Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
Experimental: ALN-AGT01 Dose Regimen 2
Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
 Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
Experimental: ALN-AGT01 Dose Regimen 3
Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
 Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
Experimental: ALN-AGT01 Dose Regimen 4
Multiple doses of ALN-AGT01 administered by SC injection during the 12-month DB treatment period.
 Drug: ALN-AGT01
ALN-AGT01 administered by SC injection
Placebo Comparator: Placebo + ALN-AGT01
Multiple doses of placebo administered by SC injection during the first 6 months of 12-month DB treatment period, followed by multiple doses of ALN-AGT01 administered by SC injection during the last 6 months of the 12-month DB treatment period.
 Drug: Placebo
Placebo administered by SC injection

Drug: ALN-AGT01
ALN-AGT01 administered by SC injection


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline at Month 3 in 24-hour Mean Systolic Blood Pressure (SBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: Baseline and Month 3 ]

Secondary Outcome Measures :
  1. Change from Baseline at Month 3 in Office SBP [ Time Frame: Baseline and Month 3 ]
  2. Change from Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM [ Time Frame: Baseline through Month 6 ]
  3. Change from Baseline at Month 6 in Office SBP [ Time Frame: Baseline through Month 6 ]
  4. Proportion of Patients with 24-hour Mean SBP Assessed by ABPM <130 mmHg and/or Reduction ≥20 mmHg without Additional Antihypertensive Medications at Month 6 [ Time Frame: Baseline through Month 6 ]
  5. Time-adjusted Change from Baseline in 24-hour Mean SBP and Diastolic Blood Pressure (DBP), Assessed by ABPM [ Time Frame: Baseline through Month 6 ]
  6. Change from Baseline in 24-hour mean DBP, Assessed by ABPM [ Time Frame: Baseline through Month 6 ]
  7. Change from Baseline in Office SBP and DBP [ Time Frame: Baseline through Month 6 ]
  8. Change in Serum Angiotensinogen (AGT) [ Time Frame: Baseline through Month 6 ]
  9. Change from Baseline in Daytime and Nighttime SBP and DBP by ABPM (Including Dipping Pattern) [ Time Frame: Baseline through Month 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04936035


Locations
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Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Medical Director Alnylam Pharmaceuticals
More Information
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Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04936035    
Other Study ID Numbers: ALN-AGT01-002
2021-001248-82 ( EudraCT Number )
First Posted: June 23, 2021    Key Record Dates
Last Update Posted: November 15, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alnylam Pharmaceuticals:
High blood pressure
Hypertension
Hypertensive
 siRNA
Angiotensinogen
AGT
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases