Evaluation of Macro- and Microvascular Responses to Lipopolysaccharide and Exenatide in Cardiovascular and Metabolic Disease Patients
- Trial ID
- 2024-519014-31-00
- Protocol
- CHDR2418
Trial statistics
Diseases & Conditions
Objectives
The primary objective of the study is to evaluate the **macrovascular** and **microvascular** responses to lipopolysaccharide (LPS) and exenatide in the context of **cardiovascular and metabolic diseases**. Understanding these vascular responses is clinically relevant as it may provide insights into the pathophysiological mechanisms underlying these diseases and potentially inform therapeutic strategies.
Participants
The clinical trial focuses on **cardiovascular and metabolic diseases** and involves a study population that includes only male participants. The age range of the participants is categorized under code "3," which typically corresponds to a specific adult age group, although the exact age range is not specified. The trial does not include a vulnerable population, and the selection criteria for participants, as well as the total number of participants, have not been provided by the sponsor. There is no information available regarding the general health status, lifestyle considerations such as diet or physical activity, or any specific inclusion or exclusion criteria for this trial. The sponsor has not disclosed the main objective of the trial.
Plans and Procedures
The clinical trial is designed to evaluate the macro- and microvascular responses to LPS and exenatide in individuals with **cardiovascular and metabolic diseases**. This study is a Phase 3 trial, which is categorized as a randomized, double-blind, controlled trial. The estimated recruitment start date is March 18, 2025, with an anticipated end date of June 18, 2025, indicating a total trial duration of approximately three months. Participants will be involved in a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This will be followed by multiple follow-up visits to monitor the participants' responses to the interventions and ensure their safety throughout the trial. The study will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the primary and secondary endpoints of the trial.
The expected length of participant involvement will span the entire duration of the trial, from the initial screening to the end-of-study visit. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to comply with the study protocol, or withdraw consent. The trial will adhere to rigorous scientific and ethical standards to ensure the validity and reliability of the results, contributing valuable insights into the treatment of cardiovascular and metabolic diseases.
Treatment
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 treatments 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 offered regarding these aspects of the clinical trial.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on March 18, 2025, with an estimated completion date of June 18, 2025. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the provided data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data is consistent with clinical trial standards. The trial's objective is to evaluate the treatment's impact on the specified medical condition, adhering to the regulatory requirements for Phase 3 trials. The efficacy outcomes will be analyzed to determine the treatment's potential benefits and inform future clinical decisions.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
The Netherlands | Not Recruiting | 18 Mar 2025 | — |
Netherlands | — | — | 30 |

