Evaluation of LY3556050 in a Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2 Study for Diabetic Peripheral Neuropathic Pain in Adults

The primary objective of this study is to demonstrate that at least one dose of **LY3556050** is superior to placebo in reducing pain intensity in adult participants with **Diabetic Peripheral Neuropathy**. This is clinically relevant as it aims to provide evidence for a potential new treatment option for managing pain associated with this condition, which is a common complication of diabetes and can significantly impact quality of life.

The clinical trial involves a total of **264 participants** diagnosed with **Diabetic Peripheral Neuropathy**. The study population includes both male and female subjects, aged 18 years and older, who have been living with either Type 1 or Type 2 Diabetes for at least six months prior to screening. Participants are required to have stable glycemic control on a consistent diabetes treatment regimen for a minimum of 90 days before the commencement of the trial. The selection process for the trial population ensures that individuals are willing to discontinue all medications taken for chronic pain conditions and adhere to reproductive and contraceptive requirements. The trial does not exclude vulnerable populations, indicating a broad inclusion of individuals who meet the specified criteria. Lifestyle considerations such as diet and physical activity are not explicitly detailed in the available data.

The clinical trial is a **randomized**, **double-blind**, **placebo-controlled** study designed to evaluate the efficacy and safety of LY3556050 in adult participants with **Diabetic Peripheral Neuropathy**. The trial aims to demonstrate that at least one dose of LY3556050 is superior to placebo in reducing pain intensity. The study will involve the administration of LY3556050 in capsule form, taken orally, with a placebo group for comparison. The trial is set to commence recruitment on February 19, 2024, and is estimated to conclude by January 31, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age, diabetes type, and glycemic control stability. Following successful screening, participants will be randomized to receive either LY3556050 or placebo. The study will include multiple follow-up visits to monitor safety, efficacy, and adherence to the study protocol. The primary endpoint is the mean change from baseline in the Average Pain Intensity Numeric Rating Scale (API-NRS). The end-of-study visit will mark the completion of the participant's involvement, where final assessments will be conducted.

The expected length of participant involvement is determined by the trial's duration, with the maximum treatment period set at 9999 days, although actual participation will be significantly shorter. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events, or withdrawal of consent. Participants are required to discontinue all medications taken for chronic pain conditions and adhere to reproductive and contraceptive requirements throughout the study.

The clinical trial involves the evaluation of **LY3556050**, an experimental medication developed by Eli Lilly and Company Limited. LY3556050 is formulated as a **capsule** and is administered **orally**. The active substance, LY3556050, is of chemical origin and functions as an SSTR4 agonist. The trial aims to assess the efficacy of LY3556050 in managing pain intensity in adult participants with diabetic peripheral neuropathic pain. The dosing regimen, including the specific dosage and frequency of administration, is determined by the study protocol, although the maximum daily and total dose amounts are not specified. The treatment period is set to a maximum of 9999 days, allowing for long-term evaluation of the medication's effects.

A **placebo** is used as a comparator in this double-blind, placebo-controlled study. The placebo is designed to match LY3556050 in appearance to maintain blinding. It does not contain any active substance and serves as a control to evaluate the true efficacy of LY3556050. The placebo is also administered orally in a capsule form, ensuring consistency in administration between the experimental and control groups. Participant compliance with the dosing schedule is monitored throughout the study to ensure the integrity of the trial results.

The efficacy of LY3556050 in the treatment of **Diabetic Peripheral Neuropathic Pain** will be assessed in a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging clinical trial. The primary endpoint for evaluating efficacy is the mean change from baseline in the Average Pain Intensity Numeric Rating Scale (API-NRS). This scale is a validated tool used to quantify pain intensity, providing a reliable measure of symptom improvement.

Participants will be assessed at various timepoints throughout the study to monitor changes in pain intensity. The trial is designed to demonstrate that at least one dose of LY3556050 is superior to placebo in reducing pain intensity. Data collection will involve the use of the API-NRS, and the analysis will focus on comparing the mean changes from baseline between the treatment and placebo groups. The study aims to provide robust evidence on the efficacy of LY3556050 in managing pain associated with diabetic peripheral neuropathy.