Safety, Tolerability, and Pharmacodynamics of AZD4144 in Atherosclerotic Cardiovascular and Chronic Kidney Disease Patients

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacodynamics** of AZD4144 in participants with established **atherosclerotic cardiovascular disease** and **chronic kidney disease**. This is clinically relevant as it aims to determine the potential therapeutic benefits and risks of AZD4144 in managing these conditions, which are significant contributors to morbidity and mortality. The study is designed as a Phase 1, randomized, double-blind, placebo-controlled, multi-centre trial, ensuring rigorous assessment of the investigational product's effects in the target population.

The clinical trial involves a total of **11 participants** diagnosed with **Chronic Kidney Disease** and **Atherosclerotic Cardiovascular Disease**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected without targeting any vulnerable populations. The general health status of the participants is characterized by the presence of the specified medical conditions. Lifestyle considerations such as diet, physical activity, or habits were not specified by the sponsor. The selection criteria for the trial population were not detailed in the provided data.

The clinical trial is a **Phase 1**, randomized, double-blind, placebo-controlled, multi-centre study designed to evaluate the safety, tolerability, and pharmacodynamics of AZD4144 in participants with established **atherosclerotic cardiovascular disease** and **chronic kidney disease**. The trial is expected to commence recruitment on March 28, 2025, and conclude by June 18, 2025. Participants will be randomly assigned to receive either the investigational product or a placebo, with neither the participants nor the investigators aware of the group assignments, ensuring the double-blind nature of the study.

The trial will involve several study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will undergo baseline assessments before the initiation of the investigational product. Subsequent follow-up visits will be scheduled at regular intervals to monitor safety, tolerability, and pharmacodynamic responses. These visits will include clinical evaluations, laboratory tests, and other relevant assessments as per the study protocol. The end-of-study visit will occur after the final dose, where comprehensive evaluations will be conducted to gather data on the primary and secondary endpoints.

Participant involvement is anticipated to last for the duration of the trial, from the initial screening through to the end-of-study visit. However, conditions such as adverse events, non-compliance with the study protocol, or withdrawal of consent may lead to early termination from the study. The trial is structured to ensure rigorous data collection and analysis, contributing valuable insights into the effects of AZD4144 in the target population.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on March 28, 2025, with an estimated completion date of June 18, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology for measuring, collecting, and analyzing these efficacy parameters, consistent with the standards of Phase 3 clinical trials. The trial will adhere to a predefined schedule for assessments, ensuring systematic data collection and analysis. The use of validated tools or instruments for efficacy assessments is implied, although specific tools are not mentioned. The trial's design and execution will align with regulatory requirements and scientific rigor to ensure the reliability and validity of the efficacy outcomes.