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LY3556050 for Diabetic Peripheral Neuropathic Pain

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are willing to discontinue all medications taken for chronic pain conditions, except allowed concomitant pain medication permitted per protocol, for the duration of the study

History of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 12

Awards & highlights

Study Summary

This trial will test a new drug to see if it can help people with diabetic neuropathic pain, over a 24wk period with 3 study periods.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects of LY3556050 are not listed here, common side effects from similar medications may include dizziness, sleepiness, nausea, headache, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to stop my chronic pain medications, except those allowed, for the study.

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I have had daily nerve pain for at least 12 weeks.

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I have had diabetic nerve pain in my legs for over 6 months.

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I have had diabetic nerve pain in both of my legs for at least 6 months.

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I have had daily nerve pain for at least 12 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS)

Secondary outcome measures

Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6)

Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a

Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b

+8 more

Side effects data

From 2021 Phase 2 trial • 202 Patients • NCT04627038

21%

Constipation

19%

Nausea

16%

Dizziness

14%

Fatigue

10%

Diarrhoea

Abdominal pain upper

Headache

Abdominal discomfort

Lethargy

Dyspepsia

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

LY3556050 600 mg

Placebo

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3556050 Dose 3Experimental Treatment1 Intervention

Participants will receive LY3556050 orally.

Group II: LY3556050 Dose 2Experimental Treatment1 Intervention

Participants will receive LY3556050 orally.

Group III: LY3556050 Dose 1Experimental Treatment1 Intervention

Participants will receive LY3556050 orally.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3556050

2021

Completed Phase 2

~520

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,189 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,335 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the regulator granted permission for LY3556050 Dose 1 to be utilized?

"As a Phase 2 trial, LY3556050 Dose 1 has some data demonstrating its safety but not yet any evidence of efficacy. Therefore, we have rated it a 2 on our scale from 1 to 3."

Answered by AI

How many healthcare facilities are conducting this experiment?

"55 sites are participating, including Headlands Research - Scottsdale in Scottsdale, Orange Grove Family Practice in Tucson, and Preferred Research Partners in Little Rock."

Answered by AI

Is participation in this experiment still available for individuals?

"The information found on clinicaltrials.gov suggests that this trial is not recruiting anymore, with the original posting dated October 6th 2023 and last edit being on October 3rd 2023. However, there are 291 other trials seeking participants at present."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

MedVadis Research Corporation

Juno Research

UniMed Center

Other

Why did patients apply to this trial?

havent tried any drugs. I have been taken 1 for nerve pain. To help with my feet hurting all the time.

PatientReceived 1 prior treatment

I have symptoms of diabetes. I have been having pains on my right leg for 2 to 3 weeks.

PatientReceived 2+ prior treatments

I've tried medications, topical creams, oils and tens units. Nothing has helped. Hoping this clinical trial will find something to help me and others with this problem.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain

2023. "A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06074562.

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