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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
Must not have
Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques.
Have a surgery planned during the study for any reason.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had a procedure in the last 6 months to permanently reduce feeling in a specific area.
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I am scheduled for surgery during the study period.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 2 trial • 202 Patients • NCT04627038
21%
Constipation
19%
Nausea
16%
Dizziness
14%
Fatigue
10%
Diarrhoea
6%
Abdominal pain upper
6%
Headache
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Diabetic Neuropathy include antiepileptic drugs like pregabalin and gabapentin, which inhibit calcium channels to reduce neurotransmitter release and neuronal excitability, and antidepressants such as duloxetine and amitriptyline, which inhibit the reuptake of serotonin and norepinephrine to enhance pain modulation pathways. These mechanisms are crucial for diabetic neuropathy patients as they target the underlying pathophysiological processes of neuropathic pain, providing symptomatic relief and improving quality of life.
Neuropathic Pain: Mechanism-Based Therapeutics.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,677 Previous Clinical Trials
3,465,221 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,714 Total Patients Enrolled
~27 spots leftby Jan 2025