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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8
Awards & highlights

Summary

This trial is testing a new medication called LY3526318 to see if it can help people with diabetic nerve pain. The study focuses on those who have chronic pain due to nerve damage from diabetes. Researchers want to find out if this drug can safely reduce their pain by blocking pain signals.

Eligible Conditions
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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 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%
Headache
3%
Nausea
3%
Diarrhoea
3%
Dizziness
2%
Vomiting
2%
Somnolence
2%
COVID-19
2%
Fatigue
2%
Vaginal discharge*a
2%
SARS-CoV-2 test positive
1%
Chest discomfort
1%
Flatulence
1%
Chest pain
1%
Hip fracture
1%
Suicidal ideation
1%
Anaemia
1%
Constipation
1%
Abdominal distentation
1%
Abdominal pain
1%
Frequent bowel movements
1%
Restless legs syndrome
1%
Tension headache
1%
Upper respiratory tract infection
1%
Bronchitis
1%
Nasopharyngitis
1%
Urinary tract infection
1%
Concussion
1%
Dental restoration failure
1%
Post procedural complication
1%
Post procedural haematoma
1%
Pain
1%
Glucose tolerance impaired
1%
Hypertriglyceridaemia
1%
Musculoskeletal chest pain
1%
Tachycardia
1%
Immunisation reaction
1%
Insomnia
1%
Respiratory disorder
1%
Cataract operation
1%
Wisdom teeth removal
1%
Hypoacusis
1%
Photopsia
1%
Lipoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
250 mg LY3526318 Week 1 to 4
Placebo Week 1 to 4
250 mg LY3526318/Placebo Week 5 to 8
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
2,640 Previous Clinical Trials
3,221,489 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
508 Total Patients Enrolled
~43 spots leftby Sep 2025
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