Pegozafermin

DRUG8 trials

Sponsors

89bio Inc., 89bio, Inc.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated CirrhosisMetabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated CirrhosisMetabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisMetabolic Dysfunction-Associated Steatotic Liver Disease(MASH) / Nonalcoholic Steatohepatitis (NASH) With FibrosisNASHSevere Hypertriglyceridemia

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

CompletedNCT04048135

89bio, Inc.NASH

Start: 2019-07-29End: 2022-01-19Updated: 2024-04-02

Phase 2

Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia

CompletedNCT04541186

89bio, Inc.Severe Hypertriglyceridemia

Start: 2020-09-01End: 2022-05-31Updated: 2024-07-25

Phase 3

To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia

CompletedNCT05852431

89bio, Inc.Severe Hypertriglyceridemia

Start: 2023-06-15End: 2026-04-09Updated: 2026-07-07

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG)

Active, not recruitingCTIS2023-503576-25-00

89bio Inc.Severe Hypertriglyceridemia

Start: 2023-09-22Target: 169Updated: 2025-07-29

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

RecruitingNCT06318169

89bio, Inc.Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Start: 2024-03-13End: 2029-02-01Target: 1350Updated: 2026-09-03

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

RecruitingNCT06419374

89bio, Inc.Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Start: 2024-05-24End: 2031-08-01Target: 762Updated: 2026-09-03

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

RecruitingCTIS2023-509912-27-00

89bio Inc.Metabolic Dysfunction-Associated Steatotic Liver Disease(MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Start: 2024-11-07Target: 260Updated: 2026-01-26

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

RecruitingCTIS2023-510395-31-00

89bio Inc.Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated Cirrhosis

Start: 2024-10-30Target: 155Updated: 2026-01-27

Related Papers

Clinical trial: Effects of pegozafermin on the liver and on metabolic comorbidities in subjects with biopsy‐confirmed nonalcoholic steatohepatitis

Alimentary Pharmacology & Therapeutics2023-09-1812 citations

Population Pharmacokinetics and Pharmacodynamics of Pegozafermin in Patients with Nonalcoholic Steatohepatitis

Clinical Pharmacology & Therapeutics2023-09-123 citations

Safety, pharmacokinetics, and pharmacodynamics of pegozafermin in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 1b/2a multiple-ascending-dose study.

2022-12-1271 citations