LY3556050 for Diabetic Peripheral Neuropathic Pain

No longer recruiting at 103 trial locations

Overseen By Thomas Schnitzer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Cancer, HIV, Substance use disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3556050 for individuals with diabetic peripheral neuropathic pain, a type of pain from nerve damage due to diabetes. The goal is to assess the safety and effectiveness of this treatment compared to a placebo (a pill with no active medication). Participants will receive one of three doses of LY3556050 or a placebo over 24 weeks. Suitable candidates have had type 1 or type 2 diabetes for at least six months and experience daily nerve pain in their legs. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Participants must stop taking all medications for chronic pain conditions, except for those allowed by the study protocol, for the duration of the study.

Is there any evidence suggesting that LY3556050 is likely to be safe for humans?

Research has shown that LY3556050 has been tested for safety in humans before. In earlier studies, some participants stopped taking LY3556050 due to side effects such as nausea, constipation, and diarrhea. These side effects occurred more frequently than in those who took a placebo, a harmless pill with no active drug. However, because LY3556050 has undergone previous human testing, it is considered generally safe for further study. Prospective trial participants should know that while the treatment has shown some side effects, it remains safe enough for continued testing in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic peripheral neuropathic pain?

Researchers are excited about LY3556050 for diabetic peripheral neuropathic pain because it offers a potentially novel approach compared to existing treatments like gabapentin, pregabalin, and duloxetine. While most current treatments focus on modulating nerve signals to reduce pain, LY3556050 may work through a different mechanism, though specific details are emerging as research continues. The drug is administered orally in various doses, providing flexibility and potentially better customization for individual patient needs. This new approach could lead to improved pain management outcomes for patients who haven't found relief with standard therapies.

What evidence suggests that LY3556050 might be an effective treatment for diabetic peripheral neuropathic pain?

Research has shown that LY3556050 could be a promising treatment for pain caused by nerve damage in people with diabetes. This trial will test different doses of LY3556050, with participants receiving either one of the doses or a placebo. The drug targets a specific part of the body linked to pain relief. Early results suggest that LY3556050 can reduce long-term pain by acting as a pain reliever. Although studies are ongoing, initial data indicated that patients taking LY3556050 reported less pain compared to those who took a placebo. This suggests that LY3556050 might relieve nerve pain for people with diabetes. ^{1 2 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Adults with diabetic peripheral neuropathic pain (DPNP) who have had Type 1 or Type 2 Diabetes for at least 6 months, a BMI ≤45 kg/m², stable blood sugar control, and consistent pain for at least 12 weeks. Participants must not plan surgeries during the study or have certain medical conditions that could affect their participation.

Inclusion Criteria

Your pain level on a scale from 0 to 100 is between 40 and 95 during screening.

I can follow the study's rules about birth control and pregnancy.

My blood sugar has been stable for the last 3 months with an HbA1c of 10 or less.

Exclusion Criteria

Have in the judgement of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.

I've had a procedure in the last 6 months to permanently reduce feeling in a specific area.

You have tested positive for HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3556050 or placebo orally to evaluate safety and efficacy

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3556050
• Placebo

Trial Overview The trial is testing LY3556050 against a placebo to see if it's safe and effective in treating DPNP. The study spans approximately six months over three periods, assessing how well LY3556050 relieves pain compared to an inactive substance.

How Is the Trial Designed?

Group I: LY3556050 Dose 3 Experimental Treatment 1 Intervention

Participants will receive LY3556050 orally.

Group II: LY3556050 Dose 2 Experimental Treatment 1 Intervention

Participants will receive LY3556050 orally.

Group III: LY3556050 Dose 1 Experimental Treatment 1 Intervention

Participants will receive LY3556050 orally.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. trials.lilly.com trials.lilly.com/en-US/trial/427360

A Study of LY3556050 in Adult Participants With ... - Lilly Trials The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain ...

2. posters.worldcongress2024.org posters.worldcongress2024.org/poster/a-phase-2-study-evaluating-sstr4-agonist-ly3556050-for-diabetic-peripheral-neuropathic-pain/

A phase 2 study evaluating SSTR4 agonist, LY3556050, for ... LY3556050 is a selective and potent SSTR4 agonist being evaluated as an oral analgesic for chronic pain.

3. trialx.com trialx.com/clinical-trials/listings/268482/a-study-of-ly3556050-in-adult-participants-with-diabetic-peripheral-neuropathic-pain/

A Study of LY3556050 in Adult Participants With Diabetic ... The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral ...

4. clinicaltrials.eu clinicaltrials.eu/inn/ly3556050/

Ly3556050 – Application in Therapy and Current Clinical ... Clinical trials are investigating LY3556050 for the treatment of osteoarthritis pain, diabetic peripheral neuropathic pain, and chronic low back pain. These ...

5. withpower.com withpower.com/trial/phase-2-neuralgia-9-2023-08b93

LY3556050 for Diabetic Peripheral Neuropathic Pain This trial is testing a new drug called LY3556050 to see if it can help reduce nerve pain in people with diabetes. The study will last several months and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06074562/a-study-of-ly3556050-in-adult-participants-with-diabetic-peripheral-neuropathic-pain

A Study of LY3556050 in Adult Participants With Diabetic ... The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral ...

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT04707157/

Trial | NCT04707157 This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of diabetic peripheral neuropathic pain.