A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
2期
已完成
NCT06074562
| 适应症 | Diabetic Peripheral Neuropathy |
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| 分期 | 2期 |
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| 申办方 | Eli Lilly and Company |
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| 状态 | 已完成 |
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| 受试者人数 | 404 人 |
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| 干预(药物) | Mazisotine |
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| 开始日期 | 2023年10月5日 |
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| 完成日期 | 2025年6月11日 |
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| 结果公布日 | 2026年7月30日 |
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摘要
The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Bayesian Model Averaging (BMA) Dose-response Model
Baseline, Week 12 · score on a scale
| Placebo | NA score on a scale |
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| Mazisotine 50 mg | NA score on a scale |
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| Mazisotine 200 mg | NA score on a scale |
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| Mazisotine 400 mg | NA score on a scale |
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| Posterior Mean Difference | -0.01 (95% CI -0.27–0.24) |
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Frequentist Repeated Measures (FRM) Analysis
Baseline, Week 12 · score on a scale
| Placebo | -1.58 ± 0.154 score on a scale |
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| Mazisotine 50 mg | -1.68 ± 0.217 score on a scale |
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| Mazisotine 200 mg | -1.25 ± 0.208 score on a scale |
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| Mazisotine 400 mg | -1.69 ± 0.214 score on a scale |
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| p-value | 0.691 |
| LS Mean Difference | -0.10 (95% CI -0.61–0.40) |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。