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

NCT06318169
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,350
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Lead sponsor
89bio, Inc.
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Start date
2024-03-13
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Number of sites
365
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Summary
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.
clinicaltrials.gov
Short title
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
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Official title
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-02-01
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First posted
2024-03-19
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Registry last updated
2026-08-05
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Primary completion date
2029-02-01
clinicaltrials.gov
Start date
2024-03-13
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Participants
1,350
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Participant count basis
Estimated
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Planned participants
1,350
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Protocol amendments
4
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Number of sites
365
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
89bio, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06318169
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ClinicalTrials.gov ID
NCT06318169
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Week 52

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

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

    Timeframe: 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.

  3. Time to First Occurrence of Disease Progression

    Timeframe: Up to 5 years

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

  1. Percent Change from Baseline in Alanine Aminotransferase at Week 52

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline, Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • 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 (m^2) (≥23 kg/m^2 for Asian participants).

Key Exclusion Criteria:

  • 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)
  • Participants taking vitamin E (>400 international units [IU]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening

Other inclusion and exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

  • 89bio Clinical Study SiteBirmingham, United StatesRecruiting
  • 89bio Clinical Study SiteChandler, United StatesRecruiting
  • 89bio Clinical Study SiteFlagstaff, United StatesActive, not recruiting
  • 89bio Clinical Study SiteGlendale, United StatesRecruiting
  • 89bio Clinical Study SiteSun City, United StatesRecruiting
  • 89bio Clinical Study SiteTucson, United StatesRecruiting
  • 89bio Clinical Study SiteTucson, United StatesRecruiting
  • 89bio Clinical Study SiteConway, United StatesActive, not recruiting
  • 89bio Clinical Study SiteLittle Rock, United StatesRecruiting
  • 89bio Clinical Study SiteNorth Little Rock, United StatesRecruiting
  • 89bio Clinical Study SiteCanoga Park, United StatesRecruiting
  • 89bio Clinical Study SiteCoronado, United StatesRecruiting
  • 89bio Clinical Study SiteEscondido, United StatesRecruiting
  • 89bio Clinical Study SiteFountain Valley, United StatesRecruiting
  • 89bio Clinical Study SiteFresno, United StatesRecruiting
  • 89bio Clinical Study SiteGardena, United StatesRecruiting
  • 89bio Clinical Study SiteHuntington Park, United StatesWithdrawn
  • 89bio Clinical Study SiteInglewood, United StatesRecruiting
  • 89bio Clinical Study SiteLa Jolla, United StatesRecruiting
  • 89bio Clinical Study SiteLancaster, United StatesRecruiting
  • 89bio Clinical Study SiteLong Beach, United StatesRecruiting
  • 89bio Clinical Study SiteLos Angeles, United StatesRecruiting
  • 89bio Clinical Study SiteMontclair, United StatesRecruiting
  • 89bio Clinical Study SiteOrange, United StatesRecruiting
  • 89bio Clinical Study SitePanorama City, United StatesWithdrawn

And 340 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)