Status:
RECRUITING
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Lead Sponsor:
Boston Pharmaceuticals
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Metabolic Dysfunction-Associated Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- Other inclusion criteria may apply.
Exclusion
- 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.
Key Trial Info
Start Date :
April 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06920043
Start Date
April 9 2025
End Date
December 1 2027
Last Update
December 24 2025
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Liver Health - Chandler
Chandler, Arizona, United States, 85224
2
Arizona Liver Health - Peoria
Peoria, Arizona, United States, 85381
3
The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
Tucson, Arizona, United States, 85712
4
Fresno Clinical Research Center
Fresno, California, United States, 93720