A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 In Participants With Osteoarthritis Pain

(OA05 Trial)

Recruiting at 30 trial locations

Overseen By Priyesh Mehta

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Seizure disorder, Cancer, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

147 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking all medications for chronic pain conditions for the duration of the study.

What is the purpose of this trial?

This trial is testing a new medication called LY3857210 to see if it can help reduce pain in people with osteoarthritis. The study focuses on those who suffer from chronic pain due to this condition and aims to find out if this new treatment can provide relief.

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 have pain rated between 40 and 95 on a scale during the screening process.

You have been experiencing pain in your knee for more than 12 weeks before the screening.

Are men, or women able to abide by reproductive and contraceptive requirements.

Exclusion Criteria

Have a positive human immunodeficiency virus (HIV) test result at screening.

You have had a problem with alcohol, illegal drugs, or painkillers within the past two years.

Have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 45 mg LY3857210 or placebo orally once daily for up to 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3852710
• LY3857210
• Placebo

Participant Groups

Group I: 45 mg LY3857210 Experimental Treatment 1 Intervention

Participants received 45 milligram (mg) 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