4 completed, 2 recruiting, 1 not yet recruiting. 3 Phase 2, 3 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 3 |
| Phase 3 | 3 | Recruiting 2, Completed 1 |
| Phase 1 | 2 | Completed 1, Not yet recruiting 1 |
Follow Pegozafermin: new trials by email Literature Review of Pegozafermin trials Research Report on Pegozafermin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Assess the Effect of Subcutaneous Injection Site on the Pharmacokinetics of Pegozafermin in Healthy Participants Pegozafermin - Healthy Volunteers | Phase 1 | Not yet recruiting | Hoffmann-La Roche | 105 | 2026-11-05 | 2026-10-19 |
| A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH Pegozafermin, Placebo - Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis | Phase 3 | Recruiting | Hoffmann-La Roche | 1800 | 2024-05-24 | 2026-10-23 |
| A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) Pegozafermin, Placebo - Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis | Phase 3 | Recruiting | Hoffmann-La Roche | 1350 | 2024-03-13 | 2026-10-23 |
| To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia Pegozafermin, Placebo - Severe Hypertriglyceridemia | Phase 3 | Completed | 89bio, Inc. | 369 | 2023-06-15 | 2026-07-07 |
| Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) BIO89-100, Placebo - NASH - Nonalcoholic Steatohepatitis | Phase 2 | Completed | 89bio, Inc. | 222 | 2021-06-04 | 2026-01-06 |
| Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia Pegozafermin, Placebo - Severe Hypertriglyceridemia | Phase 2 | Completed | 89bio, Inc. | 86 | 2020-09-01 | 2024-07-25 |
| 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 Pegozafermin, Placebo - NASH | Phase 1 / Phase 2 | Completed | 89bio, Inc. | 101 | 2019-07-29 | 2024-04-02 |
Metabolic Diseases (5) · Fatty Liver (4) · Liver Diseases (4) · Non-alcoholic Fatty Liver Disease (4) · Digestive System Diseases (3) · Dyslipidemias (2) · Fibrosis (2) · Hypertriglyceridemia (2) · Lipid Metabolism Disorders (2) · Hyperlipidemias (1)
89bio, Inc. (4) · Hoffmann-La Roche (3)
United States (6) · Puerto Rico (5) · Poland (4) · Argentina (3) · Belgium (3) · Bulgaria (3) · Canada (3) · Czechia (3) · France (3) · Georgia (3) · Germany (3) · Hungary (3) · India (3) · Italy (3) · Mexico (3)
Millie Gottwald, PharmD (1) · Teresa Parli, MD (1)
PMID 37696614, PMID 36521501, PMID 37355760, PMID 37356033, PMID 37718721
2023 (1)