← Back to Search

Other

LY3556050 for Diabetic Neuropathy

Northwestern University, Chicago, IL
LY3556050 +1 morePhase 2RecruitingResearch Sponsored by Eli Lilly and Company

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.

Eligible Conditions
  • Diabetic Neuropathy

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with Type 1 or Type 2 diabetes for at least 6 months.
Select...
Your diabetes has been well-controlled for at least 90 days before the study starts, and your HbA1c level is 10 or lower.
Select...
You have had ongoing nerve pain in your arms or legs for at least 12 weeks.
Select...
Your pain level, measured on a scale from 0 to 100, is between 40 and 95 during screening.
Select...
You have had symmetrical nerve damage in your feet for at least 6 months, as diagnosed by a score of 3 or higher on a nerve screening test.
Select...
Your body mass index is 45 or lower.

Timeline

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
6%
Headache
6%
Abdominal pain upper
5%
Abdominal discomfort
5%
Lethargy
4%
Dyspepsia
4%
Arthralgia
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,564 Previous Clinical Trials
3,180,417 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,319 Previous Clinical Trials
398,971 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?
Met criteria
Did not meet criteria
What site did they apply to?
Alliance for Multispecialty Research, LLC
Juno Research
Las Vegas Medical Research

Why did patients apply to this trial?

I have symptoms of diabetes. I have been having pains on my right leg for 2 to 3 weeks.
PatientReceived 2+ prior treatments
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.
All > Pflugerville Tx > Paid Studies Pasadena
~273 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top