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LY3857210

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment138

FDA Designations

No designations recorded

Clinical trial landscape

LY3857210 · 4 trials · 4 indications

Phase 2 3Phase 1 1
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.

Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan
Baseline through study completion, up to approximately 6 weeks

Change from baseline in brain RO of LY3857210 measured by \[18F\]-LY3818850 PET scan

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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Frequently asked questions about LY3857210

What is LY3857210 used for?

LY3857210 is an investigational small molecule being studied for the treatment of pain conditions, including osteoarthritis, diabetic peripheral neuropathic pain, and chronic low-back pain. It has also been evaluated in healthy participants. The drug is being developed by Eli Lilly and Company and is currently in Phase 2 clinical development.

Who makes LY3857210?

LY3857210 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker LLY. The drug is an investigational small molecule in Phase 2 clinical development for pain indications.

What phase is LY3857210 in?

LY3857210 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including studies in healthy participants and in patients with osteoarthritis, diabetic peripheral neuropathic pain, and chronic low-back pain. The drug is not yet approved and remains investigational.

What clinical trials is LY3857210 in?

LY3857210 has been studied in several clinical trials, including NCT05292040 in healthy participants, NCT05620563 in osteoarthritis pain, NCT05620576 in diabetic peripheral neuropathic pain, and NCT05630196 in chronic low-back pain. All of these trials have been completed.

Is LY3857210 the same as other names?

LY3857210 is the primary name for this investigational drug. No alternative names have been reported for this compound in the clinical trial records. It is identified solely by the code LY3857210 in the studies conducted by Eli Lilly and Company.