LY3857210 for Diabetic Neuropathy

No longer recruiting at 33 trial locations

Overseen By Mark Eliot Kutner

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Cancer, Fibromyalgia, HIV, Seizure, 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 drug, LY3857210, to determine if it can safely and effectively reduce pain from diabetic peripheral neuropathy, a condition where diabetes-related nerve damage causes chronic pain, usually in the feet. Participants will receive either the drug or a placebo (a pill with no active medicine) to compare results. It suits individuals with type 1 or type 2 diabetes who have experienced daily foot pain from neuropathy for at least six months. 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 pain medications for chronic pain conditions while participating in the study.

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

Research has shown that LY3857210 was tested in earlier studies for chronic pain, including pain from diabetic nerve damage. These studies found the treatment generally safe and well-tolerated, with no serious side effects reported. However, while the treatment did not cause major safety issues, it did not meet other effectiveness goals. Consequently, Eli Lilly decided to stop using it for chronic pain. Although LY3857210 appears safe, its ability to relieve pain may vary among individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic peripheral neuropathic pain?

Researchers are excited about LY3857210 for diabetic peripheral neuropathic pain because it offers a fresh approach compared to standard treatments like gabapentin or pregabalin. Unlike these traditional medications, which primarily target nerve signaling, LY3857210 acts on different pathways that could provide pain relief through a novel mechanism. This distinct action could make LY3857210 an effective option for patients who don't respond well to existing therapies, potentially offering faster relief with fewer side effects.

What evidence suggests that LY3857210 might be an effective treatment for diabetic peripheral neuropathic pain?

Research shows that LY3857210 works by blocking a protein called P2X7, which plays a role in sending pain signals. This trial will test LY3857210 to determine if it can relieve pain from diabetic nerve damage. However, earlier studies on LY3857210 for various types of long-term pain, including diabetic nerve pain, did not yield positive results. Researchers discontinued the drug because it didn't effectively reduce pain in these studies. While its mechanism is intriguing, LY3857210 has not yet been proven to help with the pain conditions tested. ^{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

Both men and women are allowed to take part in this study.

You are not required to use a male contraceptive.\n

Women of child bearing potential (WOCBP) and women not of child bearing potential (WNOCBP) may participate in this trial.

Exclusion Criteria

Have an eGFR of <30 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at Day 1 or Day 2

Evidence of Hepatitis B virus or Hepatitis C virus

Women who are pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 45 mg of 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) 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

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 ...