Health Trials

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

ConditionMetabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
Sponsor89bio, Inc.

About this trial

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 \[previously known as nonalcoholic steatohepatitis, NASH\]).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 <50.0 kilograms (kg)/meters squared (m²).

Disqualifiers

Liver disorder other than MASH.

History or evidence of hepatic decompensation.

History or evidence of hepatocellular carcinoma.

Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pegozafermin

    Biological/Vaccine

    Subcutaneous injection

  • Placebo

    Drug

    Subcutaneous injection

Treatment groups

762 Participants
are divided into 2 treatment groups
Group A: PegozaferminExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of Participants Achieving Fibrosis Regression

Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.

Time frame
Baseline through Month 24
2

Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events

Time frame
Baseline up to 5 years

Secondary outcomes

1

Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

Time frame
Baseline, up to Month 60
2

Change from Baseline in Alanine Aminotransferase (ALT) Level

Time frame
Baseline, up to Month 60
3

Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)

Time frame
Baseline, up to Month 60
4

Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)

Time frame
Baseline up to Month 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

89bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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