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LY3857210

Phase 2

Chronic Low-back Pain | Small molecule | Pain |Eli Lilly and Company|Trials Updated: Aug 13, 2024

LY3857210 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Mar 2022

LY3857210 target and mechanism

ModalitySmall molecule

Also known as LY3857210 ISA

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment416

FDA Designations

No designations recorded

LY3857210 clinical trials

LY3857210 · 3 trials · 3 indications

Phase 2 3
NCT05630196A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back PainChronic Low-back Pain
COMPLETED138 Analytics
NCT05620563A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis PainOsteoarthritis
COMPLETED147 Analytics
NCT05620576A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).Diabetic Peripheral Neuropathic Pain
COMPLETED131 Analytics
PHASE2COMPLETED
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain
Chronic Low-back PainUnlock trial analytics
PHASE2COMPLETED
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain
OsteoarthritisUnlock trial analytics
PHASE2COMPLETED
A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).
Diabetic Peripheral Neuropathic PainUnlock trial analytics

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. The data presented are the posterior mean with a 95% credible interval.

Change From Baseline in 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
Mean Overall Improvement as Measured by Patient's Global Impression of Change
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
LY3857210EXPERIMENTALParticipants received 45 milligrams (mg) of LY3857210 orally once daily for up to 8 weeks.
PlaceboPLACEBO_COMPARATORParticipants received placebo orally once daily for up to 8 weeks.
45 mg LY3857210EXPERIMENTALParticipants received 45 milligram (mg) LY3857210 orally once daily for up to 8 weeks.

Interventions

NameTypeDescription
LY3857210DRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites30

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 body mass index \<40 kilograms per meter squared (kg/m²) (inclusive). * Are willing to maint...

Countries:United StatesPuerto Rico
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Competitive Landscape -Chronic Cough Disorders 3 trials (matched to "Chronic Low-back Pain")

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Frequently asked questions about LY3857210

What is LY3857210?

LY3857210 is an investigational small molecule being developed by Eli Lilly and Company for chronic pain. It has been studied in Phase 2 clinical trials for chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis pain. It is not yet approved for any indication and remains in clinical development.

What is LY3857210 used for?

LY3857210 is being studied for the treatment of chronic pain conditions, specifically chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis pain. All three Phase 2 trials in these indications have been completed. The drug is investigational and has not been approved for any use.

Who makes LY3857210?

LY3857210 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 2 chronic pain master protocol studies evaluating the compound across multiple pain indications.

What phase is LY3857210 in?

LY3857210 is in Phase 2 development. Three Phase 2 trials under a chronic pain master protocol have been completed, and the drug is investigational, meaning it has not received FDA approval for any indication.

What clinical trials is LY3857210 in?

LY3857210 has been evaluated in three completed Phase 2 trials: NCT05630196 in chronic low-back pain, NCT05620576 in diabetic peripheral neuropathic pain, and NCT05620563 in osteoarthritis pain. All were randomized, double-blind, placebo-controlled studies conducted in the United States and Puerto Rico.

Is LY3857210 the same as LY3857210 ISA?

Yes, LY3857210 ISA is an alternative name for LY3857210, the investigational small molecule developed by Eli Lilly and Company for chronic pain. Searches for either name refer to the same compound.