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Also known as [14C]-LY3556050, LY3556050 ISA, Mazisotine
LY3556050 · 3 trials · 3 indications
* The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate 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; a higher score indicates worse outcome (greater pain severity). * The mixed-model repeated measures (MMRM) model included the fixed, centered, categorical effects of region, baseline NRS average pain score, as well as concurrent use of allowed concomitant medications (yes vs. no based on interactive web response system \[IWRS\]), and visit. The adjusted dose response value from the MMRM was used for fitting a Bayesian model averaging (BMA) dose-response model. * Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented were posterior mean with 95% credible interval.
* The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate 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; a higher score indicates worse outcome (greater pain severity). * The Least Squares (LS) Mean was calculated using a frequentist repeated measures (FRM) analysis, where Change = treatment, time interval, treatment \* time interval, region, average baseline pain severity category (mild or moderate versus \[vs.\] severe), concurrent use of allowed concomitant medication as entered in IWRS (yes versus no).
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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks. |
| Mazisotine 50 mg | EXPERIMENTAL | Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks. |
| Mazisotine 200 mg | EXPERIMENTAL | Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2 and a target maintenance dose of 200 mg BID by Week 3, which was then maintained up to Week 12. |
| Mazisotine 400 mg | EXPERIMENTAL | Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2, 200 mg BID by Week 3, and 300 mg BID by Week 4, until reaching a target maintenance dose of 400 mg BID by Week 5, which was then maintained up to Week 12. |
| 600 Milligram (mg) LY3556050 | EXPERIMENTAL | Participants received 600 mg LY3556050 twice daily (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. |
| Name | Type | Description |
|---|---|---|
| Mazisotine | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| LY3556050 | DRUG | Administered orally |
Inclusion Criteria: * Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening. * Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤1...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
LY3556050 is an investigational small molecule being developed by Eli Lilly and Company for the treatment of chronic pain. It has been studied in Phase 2 clinical trials in adults with chronic low-back pain and osteoarthritis. It is not approved for any indication and remains in clinical development.
LY3556050 is being evaluated as a treatment for chronic low-back pain and osteoarthritis, two common sources of chronic pain. Both Phase 2 studies have been completed. The drug has not been approved for these or any other indications, so it is not currently available as a prescribed therapy.
LY3556050 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 2 clinical program for the drug, including the chronic low-back pain and osteoarthritis studies conducted under its Chronic Pain Master Protocol.
LY3556050 has completed Phase 2 clinical development. Two Phase 2 trials have been completed: one in chronic low-back pain and one in osteoarthritis. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
LY3556050 has been studied in two completed Phase 2 trials. NCT04874636 evaluated the drug in 153 participants with chronic low-back pain, and NCT04627038 evaluated it in 202 participants with osteoarthritis. Both were randomized, double-blind, placebo-controlled studies conducted in the United States and Puerto Rico.
Yes. [14C]-LY3556050 and LY3556050 ISA are alternative names that refer to the same investigational compound, LY3556050. The carbon-14 labeled form, [14C]-LY3556050, is used in study settings, while LY3556050 is the primary name used for the drug in clinical development.