Phase 2 Master Protocol for Testing Multiple Drug Treatments for Chronic Pain Conditions Including Osteoarthritis of the Knee, Diabetic Neuropathic Pain, and Chronic Low Back Pain

What this Trial Is About

Researchers are conducting a master protocol study to evaluate multiple pain treatments for people experiencing chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different pain interventions by using a flexible design where specific intervention appendices ISAs can begin independently as new treatments become available. The study is sponsored by Eli Lilly and Company and is designed as a phase 2 randomized, placebo-controlled trial. Participants may receive one of several study drugs administered either intravenously or orally, including LY3016859 given through IV and LY3556050, LY3526318, and LY3857210 given orally. Each treatment group is compared to a matching placebo group. The study uses a parallel design where participants are assigned randomly to one of the intervention groups or placebo. The protocol includes disease-state addenda to define target populations and assessment scales for each pain condition. During the trial, participants undergo screening to confirm eligibility based on pain levels, history, and health status. They are monitored for outcomes such as the number of participants allocated to each intervention up to week 8. Researchers assess pain and other health measures while participants maintain consistent use of any ongoing non-drug pain therapies and discontinue other chronic pain medications except for rescue use. The study includes safety monitoring and will continue through April 2027, with results posted for each intervention.

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain