Not recruiting

Study of LY3556050 for Adults with Diabetic Peripheral Neuropathy Pain

InvestigationalNo placebo

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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 a condition known as Diabetic Peripheral Neuropathy, which is a type of nerve damage that can occur in people with diabetes, leading to pain and discomfort in the limbs. The study will evaluate a new treatment called LY3556050, which is taken in the form of a capsule. This medication is being tested to see if it can help reduce the pain intensity associated with this condition.

The purpose of the study is to determine if LY3556050 is more effective than a placebo in managing pain for individuals with Diabetic Peripheral Neuropathy. Participants in the study will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This approach is known as a double-blind study, which helps ensure the results are unbiased.

Throughout the study, participants will take the medication or placebo orally, and their pain levels will be monitored over time. The study aims to find out if different doses of LY3556050 can provide better pain relief compared to the placebo. The trial is expected to continue until early 2025, with the goal of improving treatment options for those suffering from pain due to Diabetic Peripheral Neuropathy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be at least 18 years old, have Type 1 or Type 2 Diabetes for at least 6 months, and maintain stable blood sugar levels for at least 90 days before starting the study.
Participants must agree to stop taking any medications for chronic pain and comply with reproductive and contraceptive guidelines.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for pain intensity using the Average Pain Intensity Numeric Rating Scale (API-NRS).
Step 3
Medication administration
Participants receive either the study medication LY3556050 or a placebo. The medication is administered in the form of a capsule taken orally.
The study is designed to evaluate different doses of LY3556050 to determine its effectiveness in reducing pain intensity compared to the placebo.
Step 4
Ongoing monitoring
Throughout the study, participants are monitored regularly to assess changes in pain intensity and any potential side effects.
The primary goal is to observe the mean change from baseline in pain intensity using the API-NRS.
Step 5
Completion of study
The study is expected to conclude by January 31, 2025. At the end of the study, final assessments are conducted to evaluate the overall effectiveness of the medication.

Who can join the trial?

5 criteria

Must be at least 18 years old at the time of signing the informed consent form.
Must have either Type 1 or Type 2 Diabetes for at least 6 months before the screening.
Must have stable blood sugar control on a consistent diabetes treatment plan for at least 90 days before starting the study medication. This means your diabetes management should not have changed recently.
Must be willing to stop taking all medications used for long-term pain conditions.
Must agree to follow guidelines related to pregnancy prevention and contraceptive use.

Who cannot join the trial?

5 criteria

Patients who have a different condition than Diabetic Peripheral Neuropathy cannot participate. This condition involves nerve damage caused by diabetes, leading to pain and numbness, usually in the feet and hands.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not part of the specified clinical trial group cannot participate. This group is determined by the study organizers based on specific characteristics.
Patients who are not male or female cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes individuals who may have limited ability to protect their own interests, such as children, pregnant women, or those with certain disabilities.

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Investigated drugs

LY3556050 is a medication being studied for its potential to reduce pain in adults with diabetic peripheral neuropathic pain. This trial aims to determine if LY3556050 can effectively decrease pain intensity compared to a placebo.

Ly3556050

What is already known about the treatment

LY3556050 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating diabetic peripheral neuropathic pain. It is in the experimental phase, with ongoing research to determine its safety and efficacy. The main therapeutic indication is to alleviate pain associated with diabetic peripheral neuropathy. LY3556050 works by modulating specific pathways in the nervous system to reduce pain signals. It is classified under analgesics, which are medications designed to relieve pain.

Investigated diseases

Diabetic Peripheral Neuropathy – This condition is a type of nerve damage that can occur in people with diabetes. It primarily affects the nerves in the legs and feet. Symptoms often include pain, tingling, and numbness, which can progress over time. As the condition advances, individuals may experience muscle weakness and loss of reflexes, particularly in the ankles. The progression of symptoms can lead to difficulties in walking and maintaining balance. It is a common complication of diabetes, resulting from prolonged high blood sugar levels.