LY3556050 for Diabetic Peripheral Neuropathic Pain

Recruiting at 78 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

410 Participants Needed

Trial Summary

What is the purpose of this trial?

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 will compare the effects of LY3556050 to another treatment. The goal is to determine if LY3556050 is safe and effective for treating diabetic nerve pain.

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.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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