A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBoston Pharmaceuticals
About this trial
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
Eligibility criteria
Qualifiers
Ability to understand and sign a written informed consent form (ICF)
Age 18 through 75 years at enrollment
History or presence of 2 or more of the 5 components of metabolic syndrome
Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
Disqualifiers
Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
History of type 1 diabetes
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
Other exclusion criteria may apply.
Trial design
Treatments tested in this trial
- Efimosfermin
- Placebo
Treatment groups
42 Participants
are divided into 3 treatment groupsSponsors and collaborators
Boston Pharmaceuticals
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov