Active not recruitingPHASE2INTERVENTIONAL

Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy

This study is looking into a new treatment called LY3848575 for a type of nerve pain called distal sensory polyneuropathy. This condition causes pain that typically starts in the feet and can spread up the legs, sometimes reaching just below the knee. The main goal is to find out if this new treatment is safe and how well it works to relieve pain, compared to a placebo (a dummy treatment with no active drug). Researchers are particularly interested in finding effective ways to manage this chronic pain, and this study aims to contribute to that understanding. Taking part could last up to 30 weeks.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

558

Start

22 Aug 2024

Estimated completion

01 Sep 2026

Neuropathic Pain Distal Sensory Polyneuropathy

What is this study about?

You're reading about a research study for people experiencing a specific type of nerve pain. This pain is often called distal sensory polyneuropathy, which simply means nerve damage happening furthest from the brain, typically starting in the feet and sometimes moving up the legs. This study is testing a new medication called LY3848575.

The main aim of this study is to see if LY3848575 can help reduce this type of nerve pain and if it's safe for people to use. To do this, some participants will receive the active study medication, while others will receive a placebo. A placebo looks exactly like the study medication but doesn't contain any active drug. This helps researchers understand if any improvements are truly due to the new treatment or if they happen for other reasons.

Finding effective and safe treatments for nerve pain is really important, as it can significantly impact daily life. By taking part in studies like this, you could help doctors learn more about this condition and potentially discover new ways to help many people living with nerve pain in the future.

Key takeaways

This study tests a new drug for nerve pain in the feet and legs.
It compares the new drug (LY3848575) to a dummy pill (placebo).
Participation could last up to 30 weeks.
The goal is to see if the treatment is safe and helps reduce pain.
You'll be closely monitored by a medical team.
Your involvement helps advance understanding of nerve pain.

Who may be eligible?

To join this study, your nerve pain must be ongoing in your legs (and possibly hands) for at least six months, and score at a certain level on a pain scale. It's important that this pain is mainly sensory (affecting feeling) rather than causing significant muscle weakness or issues with body functions like digestion.

There are also some things that might mean you can't join. For instance, if you've had certain procedures for pain recently, or if your diabetes isn't stable. Also, if you've had some types of cancer within the last two years (unless it was skin cancer that's now clear or chemotherapy that directly caused your nerve pain) or have plans for surgery, you might not be able to participate. The study team will check these details carefully with you.

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.

Do you have nerve pain in your feet and/or legs that has lasted at least 6 months?
Does your pain typically score 40 or higher on a pain scale (out of 100)?
Have you *not* had any procedures recently to permanently numb your painful area?
Is your diabetes well-managed and stable, if you have it?
Have you been free from most cancers in the last two years (except certain skin cancers or chemotherapy-related nerve pain)?
Are you willing to stop specific other pain medications if needed, but continue current non-drug therapies consistently?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your total time in the study could be up to 30 weeks, including an initial screening period to make sure it's right for you. Throughout the study, you'll have regular visits where the study team will monitor your health, ask about your pain levels, and check how you're responding to the treatment. You'll be given either the study medication (LY3848575) or a placebo, and it's important to take it as instructed. You'll need to keep up with any non-drug pain therapies or supplements you're already using, but you won't be able to start new ones. You'll also need to stop other chronic pain medications, except for specific ones that the study allows. The study team will provide all the details about visits, medications, and any follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study could be that you receive the active study medication, which might help reduce your pain. Even if you receive the placebo, you'll still be closely monitored by a medical team and contribute to important scientific research. Possible risks could include side effects from the medication, though these will be carefully explained and monitored. Before deciding to join, the study team will discuss all known and potential risks with you. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (76)

MD First Research - Chandler
Verified postcode
Chandler, United States
HOPE Research Institute
Verified postcode
Phoenix, United States
Neuro-Pain Medical Center
Verified postcode
Fresno, United States
Alpine Clinical Research Center
Verified postcode
Boulder, United States
Accel Research Sites - St. Pete-Largo Clinical Research Unit
Verified postcode
Largo, United States
Design Neuroscience Center
Verified postcode
Miami Lakes, United States
Conquest Research - Orlando
Verified postcode
Orlando, United States
Charter Research - Lady Lake
Verified postcode
The Villages, United States
Encore Medical Research - Weston
Verified postcode
Weston, United States
Conquest Research
Verified postcode
Winter Park, United States
Integrated Clinical Trial Services, Inc.
Verified postcode
West Des Moines, United States
Lucida Clinical Trials
Verified postcode
New Bedford, United States

Common questions

What is 'distal sensory polyneuropathy'?

It's a type of nerve damage that typically causes pain, tingling, or numbness, often starting in your feet and sometimes moving up your legs.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medication but contains no active drug. It helps researchers compare the new treatment's effects.

How long does the study last?

If you join, your participation could last for up to 30 weeks, including the initial checks to see if you're suitable.

Can I continue my current pain medications?

You may need to stop some chronic pain medications, but the study team will tell you which ones are allowed or not. Non-drug therapies or supplements you already use should continue consistently.

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

No, during the study, neither you nor the study team will know if you're receiving the active drug or the placebo. This helps keep the results fair and unbiased.