Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05086289 | Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Chronic Low Back Pain | PHASE2 | COMPLETED | 159 | — | — | Oct 25, 2021 | Jun 17, 2022 | Oct 5, 2023 | 31 | United States, Puerto Rico |
The NRS was used to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.
| Arm | Type | Description |
|---|---|---|
| LY3526318 | EXPERIMENTAL | Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period and were switched to placebo once daily for the next 4 weeks of the treatment period. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo orally, once daily, for 8-weeks treatment period. |
| Name | Type | Description |
|---|---|---|
| LY3526318 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening. * Have a history of daily pain for at least 12 weeks based on participant report or medical history. * Have a body mass index \<40 kilograms per meter squared (kg/m²) (inclusive). * Are willing to maint...