LY3857210 for Osteoarthritis

(OA05 Trial)

No longer recruiting at 31 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3857210 to determine its effectiveness in reducing knee pain for people with osteoarthritis. The study aims to assess the treatment's effectiveness and safety in managing chronic pain. Participants will receive either the actual treatment or a placebo (a harmless pill resembling the treatment but without active ingredients) to compare results. This trial may suit those who have experienced daily knee pain from osteoarthritis for over 12 weeks and are willing to stop other pain medications during the study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LY3857210, a treatment for chronic pain, has undergone safety testing. Eli Lilly, the company developing it, decided to discontinue its use for chronic pain because it did not perform as well as expected in other studies. This decision does not imply safety concerns, only that the treatment was less effective than anticipated.

Regarding safety, the available data has reported no serious side effects, suggesting participants generally tolerated the treatment well. However, since the drug is still in a mid-stage trial, not all safety details are known. Mid-stage trials indicate that the treatment has passed initial safety checks, but researchers are still confirming its safety for a larger population.

Overall, LY3857210 appears safe so far, but further research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritic pain?

Researchers are excited about LY3857210 because it targets osteoarthritis pain differently from the usual pain relievers like NSAIDs or opioids. LY3857210 works by targeting specific pathways involved in pain perception, which could mean fewer side effects often linked to standard treatments. Additionally, it is taken orally once daily, making it a convenient option for those seeking relief from chronic pain without the hassle of multiple doses or injections. This unique approach could potentially offer more effective pain management and improve quality of life for people with osteoarthritis.

What evidence suggests that LY3857210 might be an effective treatment for osteoarthritic pain?

Research has shown that LY3857210 blocks a specific part of immune cells called the P2X7 receptor, which may play a role in pain perception. However, proving its effectiveness in treating long-term pain has been challenging. In this trial, participants will receive either 45 mg of LY3857210 or a placebo. A previous study tested LY3857210 for pain from osteoarthritis and other chronic pain types but did not achieve its goals, leading to the discontinuation of its development for these conditions. Consequently, there is limited evidence that it helps reduce osteoarthritis pain. ^{1 2 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• LY3852710
• LY3857210
• Placebo

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05620563

Study Details | NCT05620563 | A Chronic Pain Master ... The main purpose of this study is to evaluate the efficacy and safety of LY3857210 in participants with Osteoarthritic Pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05620576

Study Details | NCT05620576 | A Chronic Pain Master ... This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain.

3. trial.medpath.com trial.medpath.com/news/bb4fcc6b88cf3fc2/lilly-discontinues-p2x7-inhibitor-ly3857210-for-chronic-pain-after-phase-ii-failure

Lilly Discontinues P2X7 Inhibitor LY3857210 for Chronic Pain ... The drug completed a master protocol study testing its efficacy in chronic low back pain, osteoarthritis pain, and diabetic peripheral ...

4. biospace.com biospace.com/drug-development/lilly-refines-pain-pipeline-again-scrapping-mid-stage-program

Lilly Refines Pain Pipeline Again, Scrapping Mid-Stage ... The drug, named LY3857210, is an orally available inhibitor of the P2X7 receptor that is found on a variety of immune cells and considered a key ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/lexicons-non-opioid-therapy-for-dpnp-beats-placebo-in-pain-reduction/

Lexicon's non-opioid therapy for DPNP beats placebo in ... Lexicon Pharmaceuticals' non-opioid-based therapy has outperformed placebo in 10mg doses in patients with severe diabetic peripheral neuropathic pain (DPNP).

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/painreform-first-part-prf-110-study/

PainReform reports safety results from first part of PRF-110 ... Initial data showed a solid safety profile of PRF-110 with no serious adverse events among the patients. PainReform CEO Ilan Hadar said: “We are ...