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NCT04929483 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by 89bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
NCT04929483: Completed Phase 2 study, sponsored by 89bio.
NCT04929483 is a Phase 2 study that has completed, run by 89bio. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04929483, a Phase 2 study, has completed, sponsored by 89bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
Study 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.
Primary Outcome
Nonalcoholic fatty liver disease activity score (NAS) was the sum of the scores of steatosis, inflammation, and ballooning. NAS score ranged from 0 to 8, with higher scores indicating worse disease severity. Resolution of NASH was defined as the total absence of ballooning (score=0) and absent or mild inflammation (score=0 to 1). NASH clinical research system (CRN) fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibr
Interventions
- DRUG Placebo
- DRUG BIO89-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2021-06-04 |
| Est. Completion | 2024-10-08 |
| Phase | Phase 2 |
What the finished NCT04929483 record still lists
NCT04929483 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04929483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04929483 about?
NCT04929483 is a clinical study titled "Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)". 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.
What is the current status of trial NCT04929483?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2021-06-04. Estimated completion is 2024-10-08.
What interventions are being tested in trial NCT04929483?
The interventions under investigation include: Placebo (DRUG), BIO89-100 (DRUG).
Who is sponsoring clinical trial NCT04929483?
This trial is sponsored by 89bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04929483's enrollment target sits among peer trials
222 274th of 2000 higher than 1,726 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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