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Monoclonal Antibodies

LY3526318 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
Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
Have a history of daily pain for at least 12 weeks based on participant report or medical history.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective for treating diabetic peripheral neuropathic pain.

Eligible Conditions
  • Diabetic Neuropathy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The subject has a pain value that is ≥40 on a visual analog scale (VAS), and the pain value is <95 during screening.
Select...
The participant has experienced pain for 12 weeks on a daily basis, either through participant report or medical history.
Select...
We ask that you continue any ongoing pain-relieving therapies (like physical therapy) and not start any new therapies during the study.
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The volunteers are willing to stop taking all pain medications they use to treat chronic pain conditions for the duration of the study.
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Must be 18 years old or older in order to consent to sex.
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The person has had foot pain on both sides for at least six months, which has been diagnosed using the Michigan Neuropathy Screening Instrument Part B.
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Weigh less than 40 kilograms per meter squared.
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You are a man or woman who is able to abide by reproductive and contraceptive requirements.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Secondary outcome measures
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Change From Baseline for Worst Pain Intensity as Measured by NRS
Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score
+4 more

Side effects data

From 2022 Phase 2 trial • 159 Patients • NCT05086289
3%
Dizziness
3%
Diarrhoea
3%
Nausea
3%
Headache
2%
Vomiting
2%
SARS-CoV-2 test positive
2%
COVID-19
2%
Vaginal discharge*a
2%
Somnolence
2%
Fatigue
1%
Urinary tract infection
1%
Suicidal ideation
1%
Dental restoration failure
1%
Abdominal pain
1%
Bronchitis
1%
Chest discomfort
1%
Tachycardia
1%
Tension headache
1%
Immunisation reaction
1%
Musculoskeletal chest pain
1%
Concussion
1%
Hypertriglyceridaemia
1%
Nasopharyngitis
1%
Hip fracture
1%
Upper respiratory tract infection
1%
Abdominal distentation
1%
Photopsia
1%
Restless legs syndrome
1%
Pain
1%
Constipation
1%
Flatulence
1%
Respiratory disorder
1%
Post procedural haematoma
1%
Frequent bowel movements
1%
Glucose tolerance impaired
1%
Post procedural complication
1%
Insomnia
1%
Anaemia
1%
Wisdom teeth removal
1%
Cataract operation
1%
Lipoma
1%
Chest pain
1%
Hypoacusis
100%
80%
60%
40%
20%
0%
Study treatment Arm
250 mg LY3526318 Week 1 to 4
250 mg LY3526318/Placebo Week 5 to 8
Placebo Week 1 to 4
Placebo Week 5 to 8

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3526318Experimental Treatment1 Intervention
Participants received 250 milligram (mg) of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo orally, once daily, for 8-weeks treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3526318
2021
Completed Phase 2
~510

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,515 Total Patients Enrolled
1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
5 Previous Clinical Trials
708 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Simon Williamson Clinic
What portion of applicants met pre-screening criteria?
Met criteria
~49 spots leftby Mar 2025