Chronic Pain Master Protocol (CPMP): A Study of LY3016859 in Participants With Diabetic Peripheral Neuropathic Pain

Summary

This study is being done to test the safety and efficacy of the study drug LY3016859 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.

Timeline

Start

2020-07-15

Primary completion

2021-07-08

Completion

2021-11-11

Outcome

Missed primary endpoint

registry analysis (superiority test); 750 Mg-500 mg LY3016859; Posterior Mean Difference -0.42 (95% CI -1.17 to 0.32); Bayesian Mixed Model Analysis NCT04476108 ↗

Publications

• James DE, Bailey J, van der Walt JS, Winkler J, Schoemaker R. Population Pharmacokinetics and Pharmacodynamics of Fepixnebart (LY3016859) and Epiregulin in Patients with Chronic Pain. Clin Pharmacokinet. 2025 May;64(5):757-767. doi: 10.1007/s40262-025-01506-3. Epub 2025 Apr 23.

Drugs

Indications