Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Conditions
Keywords
Liver Diseases, Fatty Liver, Digestive System Diseases, Metabolic diseases, Metabolic Dysfunction-Associated Steatohepatitis, MASH, Steatohepatitis, Metabolic dysfunction-associated steatotic liver disease, MASLD, Nonalcoholic fatty liver disease, NAFLD, Fibrosis
Brief 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.
Interventions
BIOLOGICALPegozafermin
Subcutaneous injection
OTHERPlacebo
Subcutaneous injection
Sponsors
89bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 | Week 52 | Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis |
| Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 | 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 to First Occurrence of Disease Progression | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Alanine Aminotransferase at Week 52 | Baseline, Week 52 |
| Absolute Change From Baseline in Enhanced Liver Fibrosis (ELF) Score at Week 52 | Baseline, Week 52 |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Georgia, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTReference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
89bio, Inc.
Outcome results
None listed