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Monoclonal Antibodies
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low 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
Summary
This trial is testing a new medication called LY3526318 to see if it can help people with chronic low back pain. The goal is to find out if this medication can reduce pain and be safe for patients. This study is part of a larger effort to speed up the development of new treatments for chronic pain.
Eligible Conditions
- Chronic Lower Back Pain
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 for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) at Week 4
Secondary study objectives
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 moreSide effects data
From 2022 Phase 2 trial • 159 Patients • NCT050862893%
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%
Flatulence
1%
Chest pain
1%
Chest discomfort
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 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
2,679 Previous Clinical Trials
3,465,594 Total Patients Enrolled
Study DirectorEli Lilly and Company