Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3556050 · 6 trials · 3 indications
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.
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.
PK: AUC of Metformin
PK: Cmax of Metformin
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
PK: Cmax of LY3556050 (Part 1)
PK: AUC\[0-∞\] of LY3556050 (Part 1)
PK: fe\[0-48\] of LY3556050 (Part 1)
PK: AUC\[0-24\] of LY3556050 (Part 2)
| Arm | Type | Description |
|---|---|---|
| 600 Milligram (mg) LY3556050 | EXPERIMENTAL | Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo BID every 12 hours for up to 8 weeks. |
| LY3556050 600 mg | EXPERIMENTAL | Participants received 600 mg LY3556050 twice daily (BID) every 12 hours for up to 8 weeks. |
| [14C]-LY3556050 | EXPERIMENTAL | Single dose of \[¹⁴C\]-LY3556050 administered orally |
| LY3556050 + Metformin + Iohexol | EXPERIMENTAL | LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV). |
| LY3556050 (Part A) | EXPERIMENTAL | LY3556050 administered orally. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered orally. |
| Iohexol (Part B) | OTHER | Iohexol given intravenously (IV). (Part B is optional.) |
| Metformin (Part B) | OTHER | Metformin given orally. (Part B is optional.) |
| LY3556050+ Iohexol (Part B) | EXPERIMENTAL | Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.) |
| LY3556050 + Metformin (Part B) | EXPERIMENTAL | Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.) |
| LY3556050 (Part 1) | EXPERIMENTAL | Participants will receive single ascending doses of LY3556050 orally. |
| Placebo (Part 1) | EXPERIMENTAL | Participants will receive placebo orally. |
| LY3556050 (Part 2) | EXPERIMENTAL | Participants will receive multiple ascending doses of LY3556050 orally. |
| Placebo (Part 2) | EXPERIMENTAL | Participants will receive placebo orally. |
| Name | Type | Description |
|---|---|---|
| LY3556050 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| [14C]-LY3556050 | DRUG | Administered orally |
| Metformin | DRUG | Administered orally. |
| Iohexol | DRUG | Administered IV. |
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 value of ≤30 on the pain catastrophizing scale. * Have a body mass index \<40 kilograms per ...
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LY3556050 is an investigational small molecule being studied for pain, specifically osteoarthritis and chronic low-back pain. It has also been evaluated in healthy participants for drug interaction and absorption studies. The drug is not approved and remains in clinical development.
LY3556050 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company has sponsored clinical trials of the drug in the United States and Puerto Rico.
LY3556050 has completed Phase 2 trials for osteoarthritis and chronic low-back pain, as well as Phase 1 trials in healthy participants. It is an investigational drug still in clinical development and is not FDA approved.
LY3556050 has completed four trials: NCT04627038 and NCT04874636, both Phase 2 studies under the Chronic Pain Master Protocol for osteoarthritis and chronic low-back pain, respectively, and NCT05615467 and NCT06052462, Phase 1 studies in healthy participants.
LY3556050 is the only name provided for this drug. No alternative names have been reported in the clinical trial records.