Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

J4F-MC-CYAB: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study Evaluating LY3848575 in Chronic Neuropathic Pain Associated With Distal Sensory Polyneuropathy

This research study, called J4F-MC-CYAB, is trying to find new and more effective treatments for chronic neuropathic pain, which is long-lasting pain caused by nerve damage. Specifically, it's focusing on pain in the hands and feet due to a condition called distal sensory polyneuropathy. The study is in its Phase 2, meaning it's still an early stage where we learn more about how a new medicine works and what dose might be best. Participants will be given either the new medicine, LY3848575, or a placebo (a dummy pill that looks exactly like the actual medicine) to see which is more effective at reducing pain. Neither you nor your doctor will know if you're taking the medicine or the placebo. The main goal is to measure how much, on average, a person's pain intensity changes after taking the study treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

Start

23 May 2025

Neuropathic Pain Distal Sensory Polyneuropathy

What is this study about?

This study is investigating new treatments for a specific type of long-term pain called neuropathic pain. Unlike a sprain or a cut, neuropathic pain comes from damage to your nerves. This can lead to sensations like burning, shooting pain, numbness, or tingling, often in places like your hands and feet. This particular study focuses on 'distal sensory polyneuropathy,' which means nerve damage mostly affecting the nerves further away from your body's centre, such as in your fingers and toes.

The main aim of this research is to test a new medicine, called LY3848575. We want to find out if this medicine can help reduce the amount of pain people experience. It's also important to discover the best dose of this medicine – one that provides relief with the fewest side effects. This research is in 'Phase 2,' which means it's an important step where we learn more about the medicine's effectiveness and safety before it can potentially be used more widely.

Participants in the study will be randomly assigned to receive either the new medicine or a placebo, which looks identical but contains no active ingredient. This is a common way to compare the new medicine's effects fairly. The study will carefully measure changes in pain levels to see how well the medicine works compared to the placebo. Your participation helps doctors understand if this new treatment could offer a better way for people to manage their nerve pain in the future, improving their quality of life.

Key takeaways

This study is testing a new medicine for long-term nerve pain in your hands and feet.
It's an early-stage study to find out if the medicine works and what dose is best.
Participants will receive either the new medicine or a dummy pill.
You will receive regular medical check-ups and monitoring.
Your participation could help improve future treatments for nerve pain.
You can leave the study at any time.

Who may be eligible?

The study is open to both men and women aged 18 years and older. There is no upper age limit, so older adults are welcome to participate if they meet other health requirements.

To be considered for this study, you must have neuropathic pain, specifically related to distal sensory polyneuropathy. This means your pain should be caused by nerve damage, particularly affecting your hands and/or feet.

Before you can join, a medical team will conduct a thorough check to make sure the study is right for you and that you meet all the health criteria designed to keep you safe and ensure the study results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you experience long-term pain caused by nerve damage?
Is your nerve pain mainly in your hands and/or feet?
Are you able to attend regular appointments at the study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your journey will involve a series of visits to the study clinic. During these visits, the medical team will carry out various assessments to monitor your health and how the treatment is affecting your pain. This will likely include physical examinations, questions about your pain levels, and possibly blood tests or other medical checks.

You will be given either the new medicine, LY3848575, or a placebo (a dummy pill) to take regularly, as instructed by the study doctor. Neither you nor the study staff will know whether you are receiving the active medicine or the placebo. This is called a 'double-blind' study and helps to ensure the results are unbiased. You will need to keep a record of your pain and any side effects you experience.

The study will last for a specific period, which will be fully explained to you before you agree to participate. There will also be follow-up appointments after you stop taking the study medicine to make sure you are well and to collect any final important information. The total duration of your involvement will be clearly outlined.

Potential risks and benefits

By taking part in this study, you might benefit from receiving a new medicine that could help relieve your neuropathic pain. You will also receive careful medical attention and monitoring throughout the study. However, there's no guarantee that the new medicine will work for you, and there's a chance you might receive the placebo. All medicines have potential side effects, and some are still unknown for new treatments like LY3848575. The research team will explain all known potential risks before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Poland

Common questions

What is neuropathic pain?

Neuropathic pain is a type of long-term pain caused by damage or disease affecting your nerves. It can feel like burning, shooting, stabbing, or tingling.

What does 'distal sensory polyneuropathy' mean?

It refers to nerve damage that mainly affects the nerves further away from your body's centre, often causing pain, numbness, or tingling in your hands and feet.

What is a placebo?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active ingredients. It's used to compare against the real medicine.

Will I know if I'm getting the drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving the active medicine or the placebo.

How long will I be in the study?

The total length of your participation, including follow-up, will be fully explained by the study team before you agree to join.