89bio, Inc. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2024-05-24: Study NCT06419374; Company role Lead sponsor; Phase Phase 3; Status Recruiting.
- 2024-03-13: Study NCT06318169; Company role Lead sponsor; Phase Phase 3; Status Recruiting.
- 2023-06-15: Study NCT05852431; Company role Lead sponsor; Phase Phase 3; Status Completed.
- 2021-08-16: Study NCT05022693; Company role Lead sponsor; Phase Phase 1; Status Completed.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2024-05-24 | NCT06419374 A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH | Lead sponsor | Phase 3 | Recruiting | Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis | 762 | 2031-08 |
| 2024-03-13 | NCT06318169 A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) | Lead sponsor | Phase 3 | Recruiting | Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis | 1,350 | 2029-02 |
| 2023-06-15 | NCT05852431 To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia | Lead sponsor | Phase 3 | Completed | Severe Hypertriglyceridemia | 369 | 2026-04-09 |
| 2021-08-16 | NCT05022693 PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis | Lead sponsor | Phase 1 | Completed | NASH - Nonalcoholic Steatohepatitis | 8 | 2021-12-21 |
| 2021-06-04 | NCT04929483 Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) | Lead sponsor | Phase 2 | Completed Results posted | NASH - Nonalcoholic Steatohepatitis | 222 | 2024-10-08 |
| 2020-09-01 | NCT04541186 Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia | Lead sponsor | Phase 2 | Completed Results posted | Severe Hypertriglyceridemia | 86 | 2022-05-31 |
| 2019-07-29 | NCT04048135 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 | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | NASH | 101 | 2022-01-19 |