Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Conditions
Keywords
Liver disease, Fatty Liver, Digestive System Diseases, Metabolic diseases, Metabolic Dysfunction-Associated Steatohepatitis, MASH, Nonalcoholic steatohepatitis, NASH, Metabolic dysfunction-associated steatotic liver disease, MASLD, Nonalcoholic fatty liver disease, NAFLD, Fibrosis, Cirrhosis
Brief summary
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Interventions
BIOLOGICALPegozafermin
Subcutaneous injection
DRUGPlacebo
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 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). Key
Exclusion criteria
* Liver disorder other than MASH. * History or evidence of hepatic decompensation. * History or evidence of hepatocellular carcinoma. * Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. * 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 protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Fibrosis Regression | Baseline through Month 24 | Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy. |
| Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events | Baseline up to 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Enhanced Liver Fibrosis (ELF) Score | Baseline, up to Month 60 |
| Change from Baseline in Alanine Aminotransferase (ALT) Level | Baseline, up to Month 60 |
| Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE) | Baseline, up to Month 60 |
| Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH) | Baseline up to Month 60 |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Georgia, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTReference Study ID Number: BIO89-100-132 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
Hoffmann-La Roche
Outcome results
None listed