Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mazisotine · 1 trial · 1 indication
* 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).
| 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. |
| Name | Type | Description |
|---|---|---|
| Mazisotine | DRUG | Administered orally. |
| Placebo | 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...
Mazisotine is an investigational small molecule being developed for diabetic peripheral neuropathy, a type of nerve damage caused by diabetes that can lead to pain and other symptoms. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
The specific molecular target of Mazisotine has not been disclosed in available information. It is a small molecule being studied for its potential to treat diabetic peripheral neuropathy, but its mechanism of action is not publicly detailed.
Mazisotine is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with diabetic peripheral neuropathy.
Mazisotine is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for use outside of clinical trials. The Phase 2 study has been completed, and the drug is not currently in active trials.
Mazisotine has one completed Phase 2 clinical trial, identified as NCT06074562. This study, titled "A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain," enrolled 404 participants across the United States, Czechia, Japan, Poland, and South Korea. The trial was randomized, double-blind, and placebo-controlled.
Yes, Mazisotine is also known as LY3556050. The clinical trial NCT06074562, which evaluated the drug in adults with diabetic peripheral neuropathic pain, used the name LY3556050 to refer to the investigational treatment.