NCT05986292

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

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Detailed description

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Conditions

• Osteoarthritis, Knee
• Diabetic Neuropathic Pain
• Chronic Low-back Pain

Interventions

Type	Name	Description
DRUG	LY3016859 ISA	Administered intravenously (IV)
DRUG	LY3556050 ISA	Administered orally
DRUG	LY3526318 ISA	Administered orally
DRUG	LY3857210 ISA	Administered orally
DRUG	Placebo Oral	Placebo administered orally
DRUG	Placebo	Placebo administered IV

Timeline

• Start date: 2020-01-30
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2023-08-14
• Last updated: 2026-03-27

Locations

63 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study