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Pegozafermin (Pegozafermin) | Accelerate Your Fibrosis Research

Home/Drugs/Pegozafermin

Pegozafermin

Pegozafermin

Phase 3

Sponsor: 89bio

Indication: MASH

Mechanism of Action

FGF21 Analog

Target: FGF21

Clinical Information

Approval Year

Clinical Trials (ClinicalTrials.gov)

COMPLETEDNCT04929483

Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)

Phase:PHASE2Org:89bio, Inc.

ACTIVE_NOT_RECRUITING

Relevant Publications (PubMed)

Lessons from recent clinical trials for the prevention of acute pancreatitis in chylomicronemia syndromes.

D'Erasmo L, Tramontano D, Arca M

Curr Opin Endocrinol Diabetes Obes2025 Nov 6

Role of FGF21 in Heart Failure: Molecular Insights and Therapeutic Implications.

Agrawal SP, Tannous L, Tated RC et al.

Cardiol Rev2025 Nov 3

FGF21 Analogues and MASLD: A Summary of Preclinical and Clinical Data.

Boutari C, Triantafyllou A, Papalavrentios L et al.

Curr Pharm Des2025 Aug 4

Therapeutic horizons in metabolic dysfunction-associated steatohepatitis.

Validated Models

This drug has been validated in the following preclinical models:

NCT05852431

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

Phase:PHASE3Org:89bio, Inc.

COMPLETEDNCT04048135

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

Phase:PHASE1, PHASE2Org:89bio, Inc.

COMPLETEDNCT04541186

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

Phase:PHASE2Org:89bio, Inc.

RECRUITINGNCT06419374

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

Phase:PHASE3Org:89bio, Inc.

View all trials on ClinicalTrials.gov

Newsome PN, Loomba R

J Clin Invest2025 Jul 1

Head-to-head comparison of MASH resolution index versus FAST for noninvasive prediction of resolution of MASH on biopsy.

Loomba R, Daniel PCN, Amangurbanova M et al.

Hepatology2025 May 9

View more on PubMed