Health Trials

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

ConditionMetabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
Sponsor89bio, Inc.

About this trial

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)

Biopsy-confirmed MASH with fibrosis stage F2 or F3

Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m²) (≥23 kg/m² for Asian participants).

Disqualifiers

Chronic liver diseases other than MASH

Evidence of cirrhosis on screening liver biopsy

Have type 1 diabetes or poorly controlled type 2 diabetes

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pegozafermin

    Biological/Vaccine

    Subcutaneous injection

  • Placebo

    Other intervention

    Subcutaneous injection

Treatment groups

1,350 Participants
are divided into 3 treatment groups
Group A: Pegozafermin Regimen 1Experimental treatment 1 intervention
Group B: Pegozafermin Regimen 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52

Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis

Time frame
Week 52
2

Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52

Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.

Time frame
Week 52
3

Time to First Occurrence of Disease Progression

Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events

Time frame
Up to 5 years

Secondary outcomes

1

Percent Change from Baseline in Alanine Aminotransferase at Week 52

Time frame
Baseline, Week 52
2

Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52

Time frame
Baseline, Week 52

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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