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A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).

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 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

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 more

Side effects data

From 2023 Phase 2 trial • 131 Patients • NCT05620576
6%
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

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,622 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
428,037 Total Patients Enrolled
~42 spots leftby Dec 2025
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