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LY3848575 for 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 the allowed pain medications
Be older than 18 years old
Must not have
Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest
Cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision, or cancer treatment which led to chemotherapy-induced peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
"This trial is testing a treatment for nerve pain in the feet that moves up the leg. Participants will be monitored for up to 30 weeks to see how safe and effective the treatment is compared to a
Who is the study for?
This trial is for individuals experiencing nerve pain that starts in the feet and progresses up to just below the knee, known as painful distal sensory polyneuropathy. Participants should be able to commit to a study period of up to 30 weeks.
What is being tested?
The trial is testing LY3848575 against a placebo to determine its safety and effectiveness in treating nerve pain associated with polyneuropathy. The duration of participation may last up to 30 weeks, including screening time.
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions from LY3848575 or no effects from the placebo. Side effects will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to stop taking my current chronic pain medications, except those permitted.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I've had a procedure to permanently lose feeling in a specific area within the last 6 months.
Select...
I have had cancer within the last 2 years, except for certain skin cancers or cancers that caused nerve pain due to chemotherapy.
Select...
My diabetes hasn't been under control for 3 months and my HbA1c level is above 11.
Select...
I am scheduled for surgery during the study period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3848575 Dose 3Experimental Treatment1 Intervention
LY3848575 high dose administered SC.
Group II: LY3848575 Dose 2Experimental Treatment1 Intervention
LY3848575 mid dose administered SC.
Group III: LY3848575 Dose 1Experimental Treatment1 Intervention
LY3848575 low dose administered subcutaneously (SC).
Group IV: PlaceboPlacebo Group1 Intervention
Placebo administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3848575
2023
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,465,934 Total Patients Enrolled
Study DirectorEli Lilly and Company
4 Previous Clinical Trials
741 Total Patients Enrolled