Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

J2P-MC-LXBD: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study to Evaluate LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

This research study is looking into a new medicine called LY3556050. It's designed for adults who experience ongoing pain due to diabetic peripheral neuropathy, which is nerve damage caused by diabetes. The study aims to find out if this new medicine can help reduce pain more effectively than a placebo (a dummy pill with no active medicine). Participants will be randomly given either the new medicine or the placebo, and neither they nor their doctors will know which one they are receiving until the study is over. Researchers will also be testing different doses of LY3556050 to see which one works best. This is an important step to understand if the medicine is safe and effective as a potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eli Lilly & Co.

Enrolment target

146

Start

19 Feb 2024

Diabetic Peripheral Neuropathy

What is this study about?

This study is called J2P-MC-LXBD and it's looking for a better way to treat a type of pain called diabetic peripheral neuropathic pain. This is nerve pain that can happen when diabetes damages the nerves, often in the feet and hands. It can cause tingling, numbness, burning, or shooting pain.

The main goal of this study is to test a new medicine, which has a research code name: LY3556050. This medicine is in what's called a 'Phase 2' trial. This means it has already been tested in a small number of people to check its basic safety, and now researchers want to see if it actually works to reduce pain and to find the best dose. Think of it as a crucial step before the medicine could become widely available.

To make sure the results are fair and accurate, some participants will receive the new medicine, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but contains no active ingredients. This helps researchers understand if any improvements are truly due to the new medicine or if they might be a result of other factors. Neither you nor your study doctor will know whether you are receiving the real medicine or the placebo.

Key takeaways

Tests a new medicine (LY3556050) for diabetes-related nerve pain.
Aims to reduce pain and find the best dose.
Compares the new medicine to a dummy pill (placebo).
Neither you nor your doctor will know if you're taking the real medicine or placebo.
Participation involves clinic visits and health assessments.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you must be an adult, meaning 18 years old or older. There is no upper age limit for joining.

Anyone, regardless of their gender, can potentially join this study. The most important thing is that you have been diagnosed with ongoing pain caused by diabetic peripheral neuropathy.

Beyond these basic requirements, there will be other specific health checks and tests to make sure the study is safe for you and that the results will be clear. Your doctor or the study team will go through all the detailed criteria with you to see if you are a good fit.

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?
Have you been diagnosed with pain from diabetes-related nerve damage?
Are you able to attend regular clinic visits?
Are you able to take study medication as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive the new medicine (LY3556050) or a matching dummy pill (placebo). Neither you nor your study doctor would know which one you are taking until after the study is complete. You would take this medication as instructed by the study team.

Throughout the study, you would attend several scheduled visits to the clinic or hospital. During these visits, the study team would check your health, ask about your pain levels using a special scale, and conduct various assessments like blood tests to monitor your progress and ensure your safety. You would need to keep track of your pain levels between visits. The total duration of your participation, including all visits and follow-ups, would be explained to you by the study team.

Potential risks and benefits

Taking part in this study might mean you gain access to a new medicine that could help with your pain, before it's generally available. However, there's no guarantee that you will receive the active medicine or that it will benefit you. Like all medicines, LY3556050 might have side effects, and these would be carefully explained to you. You are free 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
Poland
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Unverified
Czechia

Common questions

What is diabetic peripheral neuropathic pain?

It's a type of ongoing nerve pain, often in the feet and hands, caused by nerve damage from diabetes.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medicine but contains no active ingredients. It helps researchers fairly compare the new medicine's effects.

Will I know if I'm getting the new medicine or the placebo?

No, this study is 'double-blind', meaning neither you nor your study doctor will know until the study ends.

What does 'Phase 2' mean for a medicine?

It means the medicine has been safely tested in a small number of people, and now researchers want to see if it actually works for the condition and find the best dose.

Can I stop taking part in the study if I change my mind?

Yes, you are free to leave the study at any point, and it won't affect your regular medical care.