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

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

Currently Recruiting

This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.

Status

Currently Recruiting

Phase

PHASE3

Sponsor

89bio, Inc.

Start

2024-05-24

🧠 AI SUMMARY Key Clinical Points — generated by Claude AI

✓ Key Clinical Points

✓ Treatment being tested: Pegozafermin, a novel fibroblast growth factor 21 (FGF21) analogue, is being evaluated for efficacy and safety in patients with compensated cirrhosis (F4 fibrosis) secondary to metabolic dysfunction-associated fatty liver disease (MASH).

✓ Patient eligibility overview: The trial includes adults with biopsy-confirmed stage F4 MASH cirrhosis who maintain compensated liver function, excluding those with decompensated disease, hepatocellular carcinoma, or significant hepatic impairment.

✓ Clinical significance: This addresses a critical unmet need in MASH management, as no approved therapies currently reverse cirrhosis; demonstrating efficacy could prevent disease progression to decompensation, liver failure, and transplantation in this increasingly prevalent patient population.

AI-generated summary — verify with registry before clinical use.

Status

Recruiting

Phase

PHASE3

NCT ID

NCT06419374

Trial Summary

Sponsor: 89bio, Inc.

Participants: ALL

Start: 2024-05-24

Completion: 2028-06

Min Age: 18 Years

Max Age: 75 Years

Eligibility Criteria

Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and 400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening. Other protocol-defined inclusion and exclusion criteria may apply.

Full Trial Details

View this trial on the source registry

Eligibility criteria, protocol, and results when available

View Trial ↗

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