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Monoclonal Antibodies

LY3526318 for Chronic Lower Back Pain

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
Awards & highlights

Study Summary

This study is evaluating whether a drug called LY3526318 is effective in relieving chronic low back pain.

Eligible Conditions
  • Chronic Lower Back Pain

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 for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4
Secondary outcome measures
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
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
+5 more

Side effects data

From 2022 Phase 2 trial • 159 Patients • NCT05086289
3%
Dizziness
3%
Headache
3%
Diarrhoea
3%
Nausea
2%
Somnolence
2%
Vomiting
2%
Vaginal discharge*a
2%
Fatigue
2%
COVID-19
2%
SARS-CoV-2 test positive
1%
Wisdom teeth removal
1%
Glucose tolerance impaired
1%
Pain
1%
Hypertriglyceridaemia
1%
Insomnia
1%
Suicidal ideation
1%
Lipoma
1%
Hip fracture
1%
Nasopharyngitis
1%
Immunisation reaction
1%
Flatulence
1%
Concussion
1%
Anaemia
1%
Urinary tract infection
1%
Post procedural haematoma
1%
Post procedural complication
1%
Chest discomfort
1%
Bronchitis
1%
Constipation
1%
Dental restoration failure
1%
Chest pain
1%
Hypoacusis
1%
Photopsia
1%
Musculoskeletal chest pain
1%
Abdominal distentation
1%
Upper respiratory tract infection
1%
Abdominal pain
1%
Restless legs syndrome
1%
Tension headache
1%
Tachycardia
1%
Frequent bowel movements
1%
Respiratory disorder
1%
Cataract operation
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 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period 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
2,617 Previous Clinical Trials
3,201,041 Total Patients Enrolled
Study DirectorEli Lilly and Company

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?
Arizona
Texas
How old are they?
18 - 65
What site did they apply to?
Synexus- Chandler
Synexus - US
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain
2021. "Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05086289.
~45 spots leftby Apr 2025
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