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NCT05103332CompletedPhase 2

Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2)

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication

Source: ClinicalTrials.gov · Last updated 3 Nov 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
663 (actual)
First submitted
22 Oct 2021
Start date
5 Nov 2021
Primary completion date
11 Dec 2023
Lead sponsor
Alnylam Pharmaceuticals
NCT number
NCT05103332
EudraCT number
2021-003776-13

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 663
  • From 5 Nov 2021 to the primary completion date, 11 Dec 2023
  • 99 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received an investigational agent within the last 30 days
  • History of any cardiovascular event within 6 months prior to randomization

Other illness

  • Secondary hypertension, orthostatic hypotension
  • History of intolerance to SC injection(s)

Lab values

  • Elevated potassium \<lower limit of normal (LLN) range or \>5 milliequivalents per liter (mEq/L)
  • Estimated glomerular filtration rate (eGFR) of \<30 mL/min/1.73m\^2
  • Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, or laboratory evidence of diabetes during screening without known diagnosis of diabetes

Who the study is looking for

  • Office SBP at Screening as follows:
    • ≥155 mmHg and ≤180 mmHg for patients with untreated hypertension
    • ≥145 mmHg and ≤180 mmHg for patients on antihypertensive medications
  • 24-hour mean SBP ≥130 mmHg and ≤160 mmHg by ABPM after at least 4 weeks of run-in

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (99)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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BramptonCanadaUnknown status
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ChicoutimiCanadaUnknown status
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ConcordCanadaUnknown status
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LévisCanadaUnknown status
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LondonCanadaUnknown status
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Pointe-ClaireCanadaUnknown status
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QuébecCanadaUnknown status
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SherbrookeCanadaUnknown status
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TorontoCanadaUnknown status
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Trois-RivièresCanadaUnknown status
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WinnipegCanadaUnknown status
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FrankfurtGermanyUnknown status
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TartuEstoniaUnknown status
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BellshillUnited KingdomUnknown status
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CarshaltonUnited KingdomUnknown status
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EdinburghUnited KingdomUnknown status
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FoweyUnited KingdomUnknown status
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GlasgowUnited KingdomUnknown status
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Lancashire PrestonUnited KingdomUnknown status
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LiskeardUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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NewquayUnited KingdomUnknown status
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PlymouthUnited KingdomUnknown status
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SheffieldUnited KingdomUnknown status
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TorpointUnited KingdomUnknown status
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KaunasLithuaniaUnknown status
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VilniusLithuaniaUnknown status
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RigaLatviaUnknown status
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CzęstochowaPolandUnknown status
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GdanskPolandUnknown status
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KatowicePolandUnknown status
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StaszówPolandUnknown status
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WarsawPolandUnknown status
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WroclawPolandUnknown status
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AcworthUnited StatesUnknown status
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AmarilloUnited StatesUnknown status
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Bell GardensUnited StatesUnknown status
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Beverly HillsUnited StatesUnknown status
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BurkeUnited StatesUnknown status
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Canoga ParkUnited StatesUnknown status
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CantonUnited StatesUnknown status
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CarlsbadUnited StatesUnknown status
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ClearwaterUnited StatesUnknown status
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Coconut CreekUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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CoppellUnited StatesUnknown status
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Coral GablesUnited StatesUnknown status
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DallasUnited StatesUnknown status
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EncinitasUnited StatesUnknown status
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Garden GroveUnited StatesUnknown status
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GreensboroUnited StatesUnknown status
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HazelwoodUnited StatesUnknown status
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HollywoodUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Huntington BeachUnited StatesUnknown status
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InvernessUnited StatesUnknown status
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IrvineUnited StatesUnknown status
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JacksonUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Jefferson CityUnited StatesUnknown status
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KenoshaUnited StatesUnknown status
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Lake JacksonUnited StatesUnknown status
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Little RiverUnited StatesUnknown status
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Long BeachUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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LouisvilleUnited StatesUnknown status
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MemphisUnited StatesUnknown status
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MesaUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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Mission HillsUnited StatesUnknown status
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MonroeUnited StatesUnknown status
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NaplesUnited StatesUnknown status
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New OrleansUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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NormanUnited StatesUnknown status
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OceansideUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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Panorama CityUnited StatesUnknown status
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Pembroke PinesUnited StatesUnknown status
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PlanoUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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Santa ClaritaUnited StatesUnknown status
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SavannahUnited StatesUnknown status
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ShermanUnited StatesUnknown status
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SouthgateUnited StatesUnknown status
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South GateUnited StatesUnknown status
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SplendoraUnited StatesUnknown status
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StephenvilleUnited StatesUnknown status
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TampaUnited StatesUnknown status
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TempeUnited StatesUnknown status
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TomballUnited StatesUnknown status
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TustinUnited StatesUnknown status
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UplandUnited StatesUnknown status
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WacoUnited StatesUnknown status
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Washington D.C.United StatesUnknown status
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Winston-SalemUnited StatesUnknown status
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Winter HavenUnited StatesUnknown status
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Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.