Evaluation of Safety, Tolerability, and Pharmacokinetics of COR-1389 in Obesity and Right Heart Failure in Healthy Participants

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of COR-1389 in the context of **obesity** and **right heart failure** in healthy participants. This evaluation is clinically relevant as it aims to determine the potential therapeutic profile and safety margins of COR-1389, which could inform future treatment strategies for these conditions. No secondary objectives are specified for this study.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range categorized as **3**, which typically includes adults. The trial focuses on individuals with **obesity** and **right heart failure**, as well as healthy participants. The sponsor has not provided the total number of participants involved in the study. The trial population selection criteria include a vulnerable population, although specific inclusion or exclusion criteria have not been disclosed. Participants' general health status varies, with some having pre-existing medical conditions while others are healthy. Lifestyle considerations such as diet, physical activity, and habits have not been specified in the available data.

The clinical trial is designed to evaluate the **safety**, tolerability, and pharmacokinetics of a new investigational product, COR-1389, in healthy participants. This study is a Phase 1 trial, which is typically the first stage of testing in human subjects. The trial is structured as a randomized, double-blind, and controlled study to ensure the reliability and validity of the results. The estimated recruitment start date is September 3, 2024, with an anticipated end date of June 4, 2026, indicating an overall trial duration of approximately 21 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation to ensure participants meet the necessary health standards for inclusion in the trial. Following successful screening, 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, maintaining the double-blind nature of the study.

Throughout the trial, participants will attend regular follow-up visits to monitor their health status and collect data on the investigational product's effects. These visits will include assessments of vital signs, laboratory tests, and other relevant health evaluations. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the investigational product's safety and tolerability.

The expected length of participant involvement will vary depending on the specific protocol requirements but will generally align with the overall trial duration. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial aims to provide valuable insights into the pharmacokinetics and safety profile of COR-1389, contributing to the development of potential therapeutic options for conditions such as **obesity** and right heart failure.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial may focus solely on the experimental medication without a comparator or adjunctive treatment.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is September 3, 2024, with an anticipated end date of June 4, 2026. Although specific efficacy endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. The trial will likely employ standardized methods for data collection and analysis, consistent with clinical research protocols. The absence of detailed endpoints suggests that efficacy assessments may be exploratory, potentially involving a range of clinical and laboratory measures to evaluate the investigational product's impact. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the findings.