Evaluation of the Cardiac Safety of Multiple Doses of BI 456906 in Overweight or Obese Individuals: A Healthy Volunteer Trial

The primary objective of this study is to evaluate the effect of multiple doses of **BI 456906** on cardiac safety in individuals with overweight or obesity. This is clinically relevant as it aims to assess the cardiovascular risk associated with the administration of the investigational product, which is crucial for ensuring patient safety and determining the therapeutic viability of the treatment in this population. No secondary objectives are provided in the available data.

The clinical trial involves **healthy volunteers** with an age range categorized as adults. The study population includes both male and female participants, and it does not involve any vulnerable populations. The sponsor has not provided information regarding the total number of participants. The trial population was selected based on general health status, ensuring that participants are free from any significant medical conditions. Lifestyle considerations such as diet, physical activity, and habits are not specified. The sponsor has not disclosed specific inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the cardiac safety of multiple doses of **BI 456906** in individuals with overweight or obesity. This is a Phase 3 trial, categorized as a **healthy volunteer trial**, and is expected to commence recruitment on February 3, 2024, with an estimated completion date of May 30, 2025. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. 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, thus maintaining the integrity of the blinding process.

The sequence of study visits begins with an inclusion (screening) visit, where potential participants will be assessed for eligibility based on predefined criteria. This visit is crucial for ensuring that only suitable candidates are enrolled in the study. Following successful screening, participants will undergo a series of follow-up visits at regular intervals throughout the trial duration. These visits are designed to monitor the participants' health status, assess the investigational product's effects, and ensure adherence to the study protocol. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to gather comprehensive data on the investigational product's safety and efficacy.

The expected length of participant involvement in the trial is approximately 16 months, 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's design and procedures are meticulously structured to uphold ethical standards and ensure the collection of high-quality data, contributing to the understanding of the investigational product's cardiac safety profile in the target population.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on February 3, 2024, with an estimated completion date of May 30, 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 parameters, consistent with the standards of Phase 3 clinical trials. The study will employ validated tools and instruments to ensure the accuracy and reliability of efficacy assessments. The trial's design and execution will adhere to rigorous scientific and ethical standards to provide meaningful insights into the treatment's efficacy.