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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 is a Phase 1 study that has completed, run by 89bio. The registered enrollment target is 101 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04048135
The ClinicalTrials.gov registry entry for NCT04048135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is 89bio, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04048135 reports 0 study locations.
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.
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