A Multiple Ascending Dose Study of MK-7480 in Healthy Participants for the Treatment of Non-Alcoholic Steatohepatitis

The primary objective of this study is to evaluate the safety and tolerability of **MK-7480** in healthy participants. This is clinically relevant as it provides foundational data on the potential adverse effects and overall safety profile of the investigational drug, which is crucial for its future development and application in treating conditions such as **non-alcoholic steatohepatitis**. The study does not specify any secondary objectives.

The clinical trial focuses on **non-alcoholic steatohepatitis** and involves a study population exclusively composed of male participants. The age range of the participants is categorized under code "3," which typically corresponds to adults, although specific age details are not provided. The trial does not include a vulnerable population, and the general health status of the participants is not specified. The total number of participants is not disclosed, as the sponsor has not provided this information. The selection criteria for the trial population, including any lifestyle considerations such as diet or physical activity, are not detailed in the available data. Key inclusion or exclusion criteria are also not specified, indicating that the sponsor has not shared this information.

The clinical trial is designed to evaluate the safety and efficacy of a new investigational product in participants with **non-alcoholic steatohepatitis**. This study is a Phase 3, randomized, double-blind, controlled trial. The trial is expected to commence recruitment on January 16, 2024, and is estimated to conclude by June 11, 2024. 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 include several key visits: an initial screening visit, multiple follow-up visits, and an end-of-study visit. The screening visit will determine participant eligibility based on predefined inclusion and exclusion criteria. Follow-up visits will occur at regular intervals to monitor the participants' health, assess the investigational product's effects, and ensure adherence to the study protocol. The end-of-study visit will involve a comprehensive evaluation of the participants' health status and the collection of final data for analysis.

Participant involvement is expected to last for the duration of the trial, from the initial screening through to the end-of-study visit. However, certain conditions may lead to early termination from the study, such as adverse events, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design and procedures are structured to ensure the collection of robust and reliable data while maintaining the safety and well-being of all participants.

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 these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on January 16, 2024, with an estimated completion date of June 11, 2024. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methodology for measuring and analyzing efficacy parameters will adhere to standard clinical trial protocols, ensuring the reliability and validity of the results. The trial's design and execution will be aligned with regulatory standards to evaluate the therapeutic benefits of the investigational product.