Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
2期
已完成
NCT04929483
| 适应症 | NASH - Nonalcoholic Steatohepatitis |
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| 分期 | 2期 |
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| 申办方 | 89bio, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 222 人 |
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| 干预（药物） | BIO89-100 |
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| 开始日期 | 2021年6月4日 |
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| 完成日期 | 2023年2月14日 |
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| 结果公布日 | 2026年1月6日 |
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摘要
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.
Main Study: Number of Participants With Histological Resolution of Nonalcoholic Steatohepatitis (NASH) Without Worsening of Fibrosis
Week 24 · Participants
| Main Study: Pegozafermin 15 mg QW | 5 Participants |
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| Main Study: Pegozafermin 30 mg QW | 12 Participants |
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| Main Study: Pegozafermin 44 mg Q2W | 11 Participants |
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| Main Study: Placebo Pooled | 1 Participants |
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| p-value | <0.0001 |
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| Treatment Difference | 34.65 (95% CI 10.04–59.26) |
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Main Study: Number of Participants Who Achieved Improvement of Fibrosis ≥1 Stage Without Worsening of NASH
Week 24 · Participants
| Main Study: Pegozafermin 15 mg QW | 3 Participants |
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| Main Study: Pegozafermin 30 mg QW | 14 Participants |
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| Main Study: Pegozafermin 44 mg Q2W | 11 Participants |
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| Main Study: Placebo Pooled | 4 Participants |
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| p-value | 0.1039 |
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| Treatment Difference | 14.45 (95% CI -8.71–37.62) |
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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。