Evaluation of Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of LY3962681 in Healthy Volunteers and Patients with Parkinson's Disease

The primary objective of this study is to evaluate the **safety** and **tolerability** of LY3962681 in both healthy volunteers and patients with **Parkinson's disease**. This is clinically relevant as it aims to determine the potential adverse effects and overall acceptability of the drug, which is crucial for its further development and potential therapeutic use in managing Parkinson's disease. The study also seeks to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of LY3962681, providing insights into the drug's absorption, distribution, metabolism, and excretion, as well as its biological effects and mechanism of action in the target population.

The clinical trial involves a total of **98 participants** diagnosed with **Parkinson’s disease**. The study population includes both male and female subjects, with an age range spanning from adults to the elderly. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion and exclusion criteria. The selection process aimed to encompass a broad demographic to ensure a comprehensive understanding of the disease's impact across different age groups and genders.

The clinical trial is designed as a **randomized**, **double-blind**, **placebo-controlled** study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681. The trial consists of two parts: a single-ascending-dose study in healthy volunteers and a multiple-ascending-dose study in patients with **Parkinson's disease**. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of March 30, 2025, and an estimated end date of May 5, 2029.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational product or a placebo. The study will include multiple follow-up visits to monitor safety, collect PK/PD data, and assess tolerability. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted to ensure participant safety and gather comprehensive data.

The expected length of participant involvement will vary depending on the study arm, with healthy volunteers participating in the single-ascending-dose phase and patients with Parkinson's disease participating in the multiple-ascending-dose phase. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any other reason deemed necessary by the investigator to ensure participant safety. The trial is structured to maintain scientific rigor and integrity, ensuring that data collected is robust and reliable for future analysis.

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.

No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information on parameters or endpoints, methods, schedule for measuring, collecting, and analyzing efficacy parameters, as well as tools or instruments involved in efficacy assessments, is not included. The trial is categorized as Phase 1, with an estimated recruitment start date of March 30, 2025, and an estimated end date of May 5, 2029. Further details on efficacy assessment would typically be outlined in the trial protocol, including the use of validated scales, laboratory tests, or patient-reported outcomes, and specific timepoints for evaluation.