drugset / Trial / NCT05630196

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Chronic Low Back Pain

NCT05630196 ↗

Phase 2 Completed 138 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to assess whether LY3857210 is safe and efficacious in relieving chronic low back pain (CLBP). 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
2022-12-08
Primary completion
2023-06-09
Completion
2023-06-15

Outcome

Missed primary endpoint

registry analysis (superiority test); 45 mg LY3857210 vs Placebo; Posterior Mean Difference 0.39 (95% CI -0.22 to 1.00) NCT05630196 ↗

registry MEAN 45 mg LY3857210: -1.24 (-1.59 to -0.89) score on a scale NCT05630196 ↗

registry MEAN Placebo: -1.63 (-2.14 to -1.13) score on a scale NCT05630196 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject LY3857210 Unknown 45 mg Oral

Indications