A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.
NCT ID: NCT06675175
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2024-12-09
2025-10-27
Brief Summary
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Detailed Description
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The study will be comprised of:
* A screening period of 28 days
* Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days.
* A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration.
The total duration of the study will be approximately 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD4144
Participants will receive oral dose of AZD4144 for 28 days.
AZD4144
Oral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned.
Placebo
Participants will receive oral dose of Placebo for 28 days.
Placebo
Placebo will be given orally to randomized participants as per the arm they are assigned.
Interventions
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AZD4144
Oral solution of AZD4144 will be given to randomised participants as per the arm they have been assigned.
Placebo
Placebo will be given orally to randomized participants as per the arm they are assigned.
Eligibility Criteria
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Inclusion Criteria
1. Prior Myocardial infarction (MI) (\>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
2. Prior ischemic stroke (\>60 days from index event)
3. 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
1. Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
2. Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
3. Females of non-childbearing potential must be confirmed at the Screening visit
Exclusion Criteria
* History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
* Active systemic infection within 30 days
* Clinically significant active and chronic infections within 60 days prior to randomization
* 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
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Glendale, California, United States
Research Site
Daytona Beach, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
The Bronx, New York, United States
Research Site
Sherman, Texas, United States
Research Site
Pleven, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Gyöngyös, , Hungary
Research Site
Kistarcsa, , Hungary
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Countries
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Other Identifiers
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2024-516840-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D9441C00001
Identifier Type: -
Identifier Source: org_study_id
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