Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
Phase 2
Completed
NCT04929483
| Condition | NASH - Nonalcoholic Steatohepatitis |
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| Phase | Phase 2 |
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| Sponsor | 89bio, Inc. |
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| Status | Completed |
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| Enrollment | 222 participants |
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| Interventions | BIO89-100 |
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| Start date | Jun 4, 2021 |
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| Completion date | Feb 14, 2023 |
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| Results posted | Jan 6, 2026 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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