A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain

Recruiting at29 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess whether LY3857210 is safe and efficacious in relieving chronic low back pain (CLBP). 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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

You are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.

Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.

You have experienced continuous pain in your lower back for three months or longer, which may or may not have spread to other areas.

Exclusion Criteria

Have a seizure disorder, history of seizure (other than remote history of childhood febrile seizure), or a condition that would place the participant at increased risk of seizure, such as head injury (for example, skull fracture, cerebral contusion, concussion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm or hemorrhage.

Have surgery planned during the study for any reason, related or not to the disease state under evaluation.

You have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease.

Treatment Details

Interventions

• LY3857210 (Other)
• Placebo (Other)

Participant Groups

Group I: LY3857210 Experimental Treatment 1 Intervention

Participants received 45 milligrams (mg) of LY3857210 orally once daily for up to 8 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants received placebo orally once daily for up to 8 weeks.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University