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Study on LY3848575 for Reducing Pain in Patients with Distal Sensory Polyneuropathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for chronic neuropathic pain associated with a condition called distal sensory polyneuropathy. This condition involves nerve damage that causes pain, often in the hands and feet. The treatment being tested is a medication known by its code name, LY3848575, which is administered as a solution for injection under the skin. The study will compare the effects of LY3848575 to a placebo to see if it can reduce pain intensity in participants.

The purpose of the study is to determine if at least one dose of LY3848575 is more effective than a placebo in reducing pain. Participants in the study will receive either the medication or a placebo and will be monitored over a period to assess changes in their pain levels. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results.

Throughout the study, participants will be asked to rate their pain using a simple scale, and the results will help researchers understand the potential benefits of LY3848575 for people suffering from chronic neuropathic pain. The study aims to provide valuable information that could lead to new treatment options for those affected by this painful condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to confirm your eligibility. This includes being at least 18 years old, having experienced moderate to severe nerve pain for at least 6 months, and agreeing to stop taking any medications for chronic pain conditions. Additionally, you must not be able to become pregnant.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish a baseline for your pain levels. This will involve using a tool called the Average Pain Intensity Numeric Rating Scale (API-NRS) to measure your pain.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study medication, LY3848575, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

  4. Step 4

    Medication administration

    The medication or placebo will be administered as a subcutaneous injection, which means it will be injected under the skin. The dosage, frequency, and duration of administration will be determined by the study protocol.

  5. Step 5

    Ongoing assessments

    Throughout the study, regular assessments will be conducted to monitor changes in your pain levels using the API-NRS. These assessments will help determine the effectiveness of the medication compared to the placebo.

  6. Step 6

    Completion of the study

    The study is expected to conclude by January 29, 2027. Upon completion, your participation will help in understanding the effects of LY3848575 on chronic neuropathic pain associated with distal sensory polyneuropathy.

Who can join the trial?

4 criteria

  • Are at least 18 years or older at the time of signing the consent form.
  • Have moderate to severe nerve pain for at least 6 months before the screening.
  • Are willing to stop taking all medications used for chronic pain conditions.
  • Cannot become pregnant.

Who cannot join the trial?

6 criteria

  • Patients with any other type of pain that is not related to Neuropathic Pain or Distal Sensory Polyneuropathy cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent, cannot participate.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study.
  • Patients who are currently participating in another clinical trial cannot participate in this study.
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Investigated drugs

LY3848575 is a medication being tested to see if it can help reduce pain in people who have a condition called chronic neuropathic pain associated with distal sensory polyneuropathy. This condition causes pain due to nerve damage, often in the hands and feet. The study is trying to find out if this medication can make the pain less intense compared to not taking the medication at all. The goal is to see if this medication can be a better option for managing this type of pain.

What is already known about the treatment

LY3848575 – LY3848575 is an investigational medication currently being studied in a clinical trial for its potential to relieve chronic neuropathic pain associated with distal sensory polyneuropathy. It is administered orally in the form of a pill. The main goal of the study is to determine if LY3848575 can reduce pain intensity more effectively than a placebo. This medication works by targeting specific pathways in the nervous system that are involved in pain signaling, aiming to reduce the sensation of pain. LY3848575 is classified as a potential treatment for neuropathic pain, and its effectiveness and safety are still being evaluated in clinical research.

Investigated diseases

  • Neuropathic Pain

    Neuropathic pain is a chronic pain condition that arises from damage or dysfunction in the nervous system. It is characterized by sensations such as burning, tingling, or shooting pain, often occurring without an obvious cause. The pain can be persistent or episodic and may worsen over time. It often affects areas of the body served by the damaged nerves and can lead to increased sensitivity to touch or temperature. The condition can result from various factors, including injury, infection, or diseases affecting the nervous system. As the condition progresses, it may lead to significant discomfort and impact daily activities.

  • Distal Sensory Polyneuropathy

    Distal sensory polyneuropathy is a disorder affecting the peripheral nerves, primarily those farthest from the central nervous system, such as in the hands and feet. It is characterized by a gradual onset of numbness, tingling, or pain in these areas. Over time, the condition can lead to a loss of sensation and muscle weakness. The progression of symptoms is typically slow, and they may spread to other parts of the body. This condition can result from various causes, including diabetes, infections, or exposure to toxins. As it advances, it can significantly affect balance and coordination.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513435-24-01Protocol codeJ4F-MC-CYABEstimated enrolment450 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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