Phase 1 Randomized Double-Blind Placebo-Controlled Study on Safety, Tolerability, and Pharmacokinetics of ATX304 in Obesity/Overweight Healthy Subjects

The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of ATX304 in healthy subjects with **obesity/overweight**. This is clinically relevant as it aims to determine the potential of ATX304 as a therapeutic agent, ensuring it is safe and well-tolerated in the target population, while also understanding how the drug is absorbed, distributed, metabolized, and excreted in the body. The study is designed as a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose trial, which is critical for establishing a foundational understanding of the drug's profile before proceeding to further clinical phases.

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 participants are identified as **healthy subjects** with a medical condition of **obesity/overweight**. The trial population was selected to include a vulnerable population, although specific selection criteria are not provided. The sponsor has not disclosed the total number of participants involved in the study. Relevant lifestyle considerations such as diet, physical activity, or habits have not been specified. The sponsor has not provided detailed information regarding key inclusion or exclusion criteria for this trial.

The clinical trial is a **Phase 1**, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to assess the safety, tolerability, and pharmacokinetics of ATX304 in healthy subjects with **obesity/overweight**. The trial is set to commence recruitment on August 26, 2024, and is expected to conclude by June 3, 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 a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will undergo baseline assessments before the administration of the investigational product. Subsequent follow-up visits will be scheduled to monitor safety, collect pharmacokinetic data, and assess tolerability. These visits will occur at regular intervals throughout the study duration. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to evaluate the overall impact of the treatment.

Participant involvement is expected to last for the entire duration of the trial, from the initial screening visit through to the end-of-study visit. However, conditions such as adverse events, non-compliance with study procedures, or withdrawal of consent may lead to early termination from the study. The trial is structured to ensure rigorous monitoring and data collection, contributing to the understanding of ATX304's safety profile and pharmacokinetics 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 the administration, dosing schedules, or participant compliance monitoring for these treatments.

Due to the lack of available data, further specifics regarding the **experimental medication** and any **non-experimental treatments** cannot be described. The absence of this information limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.

The clinical trial is designed to assess efficacy within a Phase 3 framework. The trial is scheduled to commence recruitment on August 26, 2024, with an estimated completion date of June 3, 2025. Efficacy assessments will be conducted at predetermined intervals throughout the trial period. The specific parameters or endpoints for evaluating efficacy have not been detailed in the available data. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that efficacy is measured accurately and consistently. The methods and tools for collecting and analyzing efficacy data will be aligned with established clinical trial protocols, although specific instruments or scales are not mentioned in the provided information.