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LY3556050

Phase 2

Chronic Low-back Pain | Small molecule | Musculoskeletal |Eli Lilly and Company|Last Updated: Nov 2, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment153
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04874636Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back PainPHASE2 COMPLETED 153May 20, 2021Feb 9, 2022Nov 2, 202335 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Change From Baseline for Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)
Baseline, Week 8

The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Secondary Endpoints
Change From Baseline on the Roland Morris Disability Questionnaire (RMDQ)
Baseline, Week 8
Change From Baseline for Overall Improvement as Measured by Patient's Global Impression of Change
Baseline, Week 8
Change From Baseline for Worst Pain Intensity as Measured by NRS
Baseline, Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
600 Milligram (mg) LY3556050EXPERIMENTALParticipants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks.
PlaceboPLACEBO_COMPARATORParticipants received placebo BID every 12 hours for up to 8 weeks.
Interventions
NameTypeDescription
LY3556050DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * 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. * Have a value of ≤30 on the pain catastrophizing scale. * Have a body mass index \<40 kilograms per ...

Countries:United StatesPuerto Rico
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