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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06318169
Registration number
NCT06318169
Ethics application status
Date submitted
13/03/2024
Date registered
19/03/2024
Date last updated
8/07/2025
Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
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Scientific 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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Secondary ID [1]
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BIO89-100-131
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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0
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0
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Liver
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Metabolic and Endocrine
0
0
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0
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Metabolic disorders
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Diet and Nutrition
0
0
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0
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Obesity
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Inflammatory and Immune System
0
0
0
0
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Connective tissue diseases
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pegozafermin
Other interventions - Placebo
Experimental: Pegozafermin Regimen 1 -
Experimental: Pegozafermin Regimen 2 -
Placebo comparator: Placebo - Matched Placebo will be administered in Regimens 1 and 2.
Treatment: Other: Pegozafermin
Subcutaneous injection
Other interventions: Placebo
Subcutaneous injection
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Participants With at Least an Improvement of Fibrosis =1 Stage Without Worsening of MASH/NASH at Week 52
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Assessment method [1]
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Worsening of NASH is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
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Timepoint [1]
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Week 52
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Primary outcome [2]
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Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52
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Assessment method [2]
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Resolution of NASH 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.
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Timepoint [2]
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Week 52
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Primary outcome [3]
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Time to First Occurrence of Disease Progression
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Assessment method [3]
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Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events
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Timepoint [3]
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Up to 240 weeks
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Secondary outcome [1]
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Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [2]
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Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36
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Assessment method [2]
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Timepoint [2]
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Baseline, Week 52
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Eligibility
Key inclusion criteria
Key
* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
* Biopsy-confirmed MASH (previously named NASH) with fibrosis stage F2 or F3 per NASH clinical research network (CRN) System and NAS =4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS <4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).
* Body mass index (BMI) at screening =25.0 kilograms (kg)/meters squared (m^2) (=23 kg/m^2 for Asian countries)
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Minimum age
18
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Chronic liver diseases other than MASH/NASH
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2029
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Actual
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Sample size
Target
1050
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,West Australi
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Recruitment hospital [1]
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89bio Clinical Study Site - Brisbane
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89bio Clinical Study Site - Herston
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89bio Clinical Study Site - South Brisbane
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89bio Clinical Study Site - Adelaide
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89bio Clinical Study Site - Bedford Park
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89bio Clinical Study Site - Clayton
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89bio Clinical Study Site - Heidelberg
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89bio Clinical Study Site - Perth
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89bio Clinical Study Site - Fitzroy
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Recruitment postcode(s) [1]
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4120 - Brisbane
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Recruitment postcode(s) [2]
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4019 - Herston
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4101 - South Brisbane
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3084 - Heidelberg
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6000 - Perth
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
89bio, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).
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Trial website
https://clinicaltrials.gov/study/NCT06318169
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Millie Gottwald, PharmD
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Address
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89bio, Inc.
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ENLIGHTEN clinical trial
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1-415-432-9270
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[email protected]
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Results not provided in
https://clinicaltrials.gov/study/NCT06318169
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