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LY3556050 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

Summary

This study is being done to test the safety and efficacy of the study drug LY3556050 for the treatment of chronic low back pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic 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)
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 on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) Health State Index (United States Algorithm)
+4 more

Side effects data

From 2021 Phase 2 trial • 202 Patients • NCT04627038
21%
Constipation
19%
Nausea
16%
Dizziness
14%
Fatigue
10%
Diarrhoea
6%
Abdominal pain upper
6%
Headache
5%
Abdominal discomfort
5%
Lethargy
4%
Dyspepsia
4%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
LY3556050 600 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 600 Milligram (mg) LY3556050Experimental Treatment1 Intervention
Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo BID every 12 hours for up to 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3556050
2021
Completed Phase 2
~520

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Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,957 Total Patients Enrolled
Study DirectorEli Lilly and Company
~36 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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