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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
5/11/2024

Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants with MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Scientific title
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Secondary ID [1] 0 0
BIO89-100-131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Dysfunction-associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) with Fibrosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants With at Least an Improvement of Fibrosis =1 Stage Without Worsening of MASH/NASH at Week 52
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36
Timepoint [2] 0 0
Baseline, Week 52
Secondary outcome [3] 0 0
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events
Timepoint [3] 0 0
Up to Month 36

Eligibility
Key inclusion criteria
Key

* Males or non-pregnant females aged between 18 and 75 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 CRN System and NAS =4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation (qualifying biopsy must be either within 6 months of screening visit [with additional requirements] or obtained during screening period)
* Body mass index (BMI) at screening =25.0 (=23 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2)

Key
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Chronic liver diseases other than MASH/NASH
* History or 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) must be on stable dose for at least 6 months prior to screening

Other inclusion and exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2029
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
89bio Clinical Study Site - Brisbane
Recruitment hospital [2] 0 0
89bio Clinical Study Site - Herston
Recruitment hospital [3] 0 0
89bio Clinical Study Site - Clayton
Recruitment hospital [4] 0 0
89bio Clinical Study Site - Heidelberg
Recruitment postcode(s) [1] 0 0
4120 - Brisbane
Recruitment postcode(s) [2] 0 0
4019 - Herston
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
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United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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Nevada
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United States of America
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New Jersey
Country [16] 0 0
United States of America
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New Mexico
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Israel
State/province [28] 0 0
Jerusalem
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Buckinghamshire
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Stockton
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
89bio, Inc.
Address
Country

Ethics approval
Ethics application status

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 \[NASH\]).
Trial website
https://clinicaltrials.gov/study/NCT06318169
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Millie Gottwald, PharmD
Address 0 0
89bio, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ENLIGHTEN clinical trial
Address 0 0
Country 0 0
Phone 0 0
1-415-432-9270
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06318169