A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).

Recruiting at 32 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

131 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing LY3857210, a new drug, to see if it can help people with diabetic nerve pain. It aims to reduce pain by altering how nerves send pain signals.

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.

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

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

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

Treatment Details

Interventions

• LY3852710
• LY3857210
• Placebo

Participant Groups

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