A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
Sponsor89bio, Inc.
About this trial
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 \[previously known as nonalcoholic steatohepatitis, NASH\]).
Eligibility criteria
Qualifiers
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 (m²).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pegozafermin
- Placebo
Treatment groups
762 Participants
are divided into 2 treatment groupsLocations
317Argentina
89bio Clinical Study SiteC1012AAR, Buenos Aires Argentina
89bio Clinical Study SiteC1125ABE, Buenos Aires Argentina
89bio Clinical Study SiteC1199ABB, Buenos Aires Argentina
89bio Clinical Study SiteC1425BGH, Buenos Aires Argentina
Sponsors and collaborators
89bio, Inc.
Lead sponsor
Source ClinicalTrials.gov