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45 mg LY3857210 for Diabetic Neuropathy
Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Summary
This trial is testing LY3857210, a new drug, to see if it can help people with diabetic nerve pain. It aims to reduce pain by altering how nerves send pain signals.
Eligible Conditions
- Diabetic Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Secondary study objectives
Change From Baseline for Worst Pain Intensity as Measured by NRS
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGIC)
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
+4 moreSide effects data
From 2023 Phase 2 trial • 131 Patients • NCT056205766%
Urinary tract infection
5%
Headache
5%
Pain in extremity
3%
Vulvovaginal candidiasis
3%
Neuropathy peripheral
2%
Dizziness
1%
Back pain
1%
Cellulitis
1%
Subcutaneous abscess
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
45 mg LY3857210
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 45 mg LY3857210Experimental Treatment1 Intervention
Participants received 45 milligram (mg) of LY3857210 orally once daily for up to 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo orally once daily for up to 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3857210
2022
Completed Phase 2
~430
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,852 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,247 Total Patients Enrolled
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