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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Santa Sp. z o.o. Lodz Poland
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Revit Sp. z o.o. Bialystok Poland
Mhkpdzgsq Itmivvirtf Cktbhfno Sapxfeir Shs z ocxf Warsaw Poland
Fltixpkehz Gqmq Offenbach Am Main Germany
Cyvlqfk Bfzyk Kodriysghkq Pumdlxbf Sac z oxll Gdansk Poland
Nibakdhnlw Ski z odrn sfkke Katowice Poland
Snitzfiyybagmo Dld Bmdtuvs Guwu Böblingen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
09.06.2025
Poland Poland
Not recruiting
09.06.2025

Trial locations

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.

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 ID:
2024-513435-24-01
Protocol code:
J4F-MC-CYAB
Trial Phase:
Therapeutic exploratory (Phase II)

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