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

Launched by ASTRAZENECA · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called AZD4144 to see how safe it is and how well it works in people with two specific health conditions: atherosclerotic cardiovascular disease (ASCVD), which affects the heart and blood vessels, and chronic kidney disease (CKD). The study aims to gather information on how the medicine affects the body after being taken by mouth. Participants in this trial will be closely monitored for any side effects and how their bodies respond to the treatment.

To be eligible for this trial, participants must be between 65 and 74 years old, or between 29 and 219 years old, and have a history of heart problems such as a previous heart attack or stroke, as well as chronic kidney disease with certain lab results. Women must have a negative pregnancy test, and all participants must follow guidelines to avoid pregnancy during the study. Those who are currently experiencing severe infections or have had certain recent medical events will not be able to participate. If you join the study, you can expect regular check-ups and support from the research team throughout the trial.

Gender

ALL

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