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

NCT06675175

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Chronic Kidney Disease, Atherosclerotic Cardiovascular Disease

Interventions: AZD4144, Placebo

Countries: United States, Bulgaria, Hungary, Romania

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Participants with established ASCVD history of one or more of the following

  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

Key Exclusion Criteria:

* History of malignancy within the last 5 years
* 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

Locations (15)

Glendale, California, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Farmington Hills, Michigan, United States
The Bronx, New York, United States
Sherman, Texas, United States
Pleven, Bulgaria
Sofia, Bulgaria
Gyöngyös, Hungary
Kistarcsa, Hungary
Bucharest, Romania
Cluj-Napoca, Romania