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NCT04048135 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH
A Phase 1 study, sponsored by 89bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 101
- Enrollment target
NCT04048135: Completed Phase 1 study, sponsored by 89bio.
NCT04048135 is a Phase 1 study that has completed, run by 89bio. The registered enrollment target is 101 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04048135, a Phase 1 study, has completed, sponsored by 89bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 101 participants
- Enrollment target
Study Summary
Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy confirmed NASH and fibrosis stages F1-F3 to be enrolled. Part 2: This is a multi-center, open label evaluation of pegozafermin at 27 mg administered weekly for 20 weeks in participants with biopsy-proven NASH (NAS ≥4, fibrosis stage F2 or F3).
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs occurring at or after the first dose date and time, through study termination, or existing prior to the time of and worsening after the time of the first dose of investigational product. A summary of other non-serious AEs and all serious AEs, regardless of causali
Interventions
- OTHER Placebo
- DRUG Pegozafermin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2019-07-29 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 1 |
What the finished NCT04048135 record still lists
NCT04048135 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04048135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04048135 about?
NCT04048135 is a clinical study titled "A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH". Part 1: This is a multi-center evaluation of pegozafermin (administered weekly or every other week) in a randomized, double-blind, placebo-controlled study administered for 12 weeks in participants with NASH and NAFLD at high risk of NASH, including a pre-defined number of participants with biopsy c...
What is the current status of trial NCT04048135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2019-07-29. Estimated completion is 2022-01-19.
What interventions are being tested in trial NCT04048135?
The interventions under investigation include: Placebo (OTHER), Pegozafermin (DRUG).
Who is sponsoring clinical trial NCT04048135?
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 NCT04048135's enrollment target sits among peer trials
101 546th of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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