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NCT06675175CompletedPhase 1

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease

Source: ClinicalTrials.gov · Last updated 25 Nov 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
29 (actual)
First submitted
4 Nov 2024
Start date
9 Dec 2024
Primary completion date
27 Oct 2025
Lead sponsor
AstraZeneca
NCT number
NCT06675175
EU CT number
2024-516840-24-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 29
  • From 9 Dec 2024 to the primary completion date, 27 Oct 2025
  • 19 sites in 4 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

  • History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
  • Clinically significant active and chronic infections within 60 days prior to randomization

Other illness

  • History of malignancy within the last 5 years
  • Active systemic infection within 30 days
  • Clinically significant recurrent infection (≥ 2× during the last 12-month period).
  • Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury in the past 12 month

Who the study is looking for

  • Participants with established ASCVD history of one or more of the following
    • Prior Myocardial infarction (MI) (\>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
    • Prior ischemic stroke (\>60 days from index event)
    • Symptomatic Peripheral Arterial Disease
  • Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to \< 60 mL/min/1.73 m2
  • Serum hsCRP \> 2 mg/L
  • Body mass index ≥ 18 to ≤ 45 kg/m2
  • All females must have a negative pregnancy test at the Screening Visit and at the randomization visit
    • Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
    • Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
    • Females of non-childbearing potential must be confirmed at the Screening visit

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Multi-profile Hospital for Active Treatment Heart and Brain EAD
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PlevenBulgariaCompleted
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
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SofiaBulgariaCompleted
University Hospital St. Anna
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SofiaBulgariaCompleted
Acibadem City clinic University Hospital EOOD
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SofiaBulgariaCompleted
Semmelweis University
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Budapest VIIIHungaryCompleted
Clinexpert Kft.
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GyongyosHungaryCompleted
CRU Hungary Kft.
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KistarcsaHungaryCompleted
Arensia Clinics S.R.L.
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BucharestRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaCompleted
Nova-Clin Medical Research Center S.R.L.
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TimisoaraRomaniaCompleted
-
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Daytona BeachUnited StatesUnknown status
-
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Farmington HillsUnited StatesUnknown status
-
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GlendaleUnited StatesUnknown status
-
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JacksonvilleUnited StatesUnknown status
-
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MiamiUnited StatesUnknown status
-
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Port OrangeUnited StatesUnknown status
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ShermanUnited StatesUnknown status
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TampaUnited StatesUnknown status
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The BronxUnited StatesUnknown status

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