A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
Фаза 2
Завершено
NCT06074562
| Заболевание | Diabetic Peripheral Neuropathy |
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| Фаза | Фаза 2 |
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| Спонсор | Eli Lilly and Company |
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| Статус | Завершено |
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| Участники | 404 участн. |
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| Вмешательство | Mazisotine |
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| Дата начала | 5.10.2023 |
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| Дата завершения | 11.06.2025 |
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| Публикация результатов | 30.07.2026 |
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Кратко
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) |
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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 |
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| LS Mean Difference | -0.10 (95% CI -0.61–0.40) |
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