Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY4065967 · 6 trials · 5 indications
Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Part D: PK: Cmax of Rosuvastatin
Part D: PK: AUC of Rosuvastatin
| Arm | Type | Description |
|---|---|---|
| LY4065967 | EXPERIMENTAL | LY4065967 administered orally. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered orally. |
| LY4065967 (Reference) | EXPERIMENTAL | Administered orally as a capsule in one of three treatment periods. |
| LY4065967 (Test 1) | EXPERIMENTAL | Administered orally as a tablet in one of three treatment periods. |
| LY4065967 (Test 2) | EXPERIMENTAL | Administered orally as a formulated capsule in one of three treatment periods. |
| [14C]-LY4065967 Part 1 | EXPERIMENTAL | A single dose containing \[14C\]-LY4065967. |
| LY4065967 Part 2 | EXPERIMENTAL | A single dose of LY4065967 followed by a single dose of \[14C\]-LY4065967. |
| LY4065967 Part A | EXPERIMENTAL | A single dose of LY4065967 administered orally |
| Placebo Part A | PLACEBO_COMPARATOR | Placebo administered orally |
| LY4065967 Part B | EXPERIMENTAL | Multiple doses of LY4065967 administered orally |
| Placebo Part B | PLACEBO_COMPARATOR | Placebo administered orally |
| LY4065967 and Rosuvastatin Part D | EXPERIMENTAL | LY4065967 and Rosuvastatin administered orally |
| Name | Type | Description |
|---|---|---|
| LY4065967 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally |
| LY4065967 Tablet | DRUG | Administered orally |
| LY4065967 Formulated Capsule | DRUG | Administered orally |
| LY4065967 Capsule | DRUG | Administered orally |
| [14C]-LY4065967 Oral | RADIATION | Oral dose |
| [14C]-LY4065967 IV | RADIATION | IV dose |
| Rosuvastatin | DRUG | Administered orally |
Inclusion Criteria: * Have a history of low back pain for at least 3 months located between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation * Have a body mass index at screening of ≤40 kilograms per meter squared (kg/m²). * Have stable glycemic control as indicated...
LY4065967 is an investigational small molecule being studied for pain conditions, including diabetic peripheral neuropathic pain, chronic low back pain, and osteoarthritis knee pain. It is also being evaluated in healthy Japanese participants in an early-phase study. The drug is in Phase 2 clinical development and is not yet approved.
LY4065967 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting clinical trials of this investigational small molecule for chronic pain indications.
LY4065967 is in Phase 2 clinical development. It is being studied in multiple Phase 2 trials for chronic pain conditions, including diabetic peripheral neuropathic pain, chronic low back pain, and osteoarthritis knee pain. A Phase 1 study in healthy Japanese participants has been completed.
LY4065967 is being studied in several trials. NCT07285018 is a Phase 2 study in diabetic peripheral neuropathic pain. NCT07641504 is a Phase 2 study in chronic low back pain. NCT07641517 is a Phase 2 study in osteoarthritis knee pain. A Phase 1 study, NCT06594159, in healthy Japanese participants has been completed.
Yes, LY4065967 is being studied for osteoarthritis knee pain. The Phase 2 trial NCT07641517 is recruiting participants with osteoarthritis of the knee and chronic pain, with enrollment in the United States and Puerto Rico.