A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Arizona Liver Health - Chandler
RECRUITING
Chandler
Arizona Liver Health - Peoria
RECRUITING
Peoria
The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
RECRUITING
Tucson
California
Fresno Clinical Research Center
RECRUITING
Fresno
OM Research LLC
RECRUITING
Lancaster
Knowledge Research Center
RECRUITING
Orange
California Liver Research Institute
RECRUITING
Pasadena
Inland Empire Liver Foundation
RECRUITING
Rialto
Santa Maria Gastroenterology Center
RECRUITING
Santa Maria
Florida
ClinCloud Research - Maitland
RECRUITING
Maitland
Advanced Clinical Research of Miami
RECRUITING
Miami
Georgia
Centricity Research - Columbus
RECRUITING
Columbus
Gastrointestinal Specialists of Georgia PC
RECRUITING
Marietta
Maryland
Mercy Medical Center - Baltimore, Maryland
RECRUITING
Baltimore
Missouri
Kansas City Research Institute
RECRUITING
Kansas City
Mississippi
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
RECRUITING
Flowood
North Carolina
Coastal Research Institute, LLC
RECRUITING
Fayetteville
M3 Wake Research, Inc
RECRUITING
Raleigh
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Texas
American Research Corporation - Austin, TX
RECRUITING
Austin
IMA Clinical Research - Austin, TX
RECRUITING
Austin
Pinnacle Clinical Research - Austin, TX
RECRUITING
Austin
The Liver Institute at Methodist Dallas Medical Center
RECRUITING
Dallas
Pinnacle Clinical Research - Georgetown
RECRUITING
Georgetown
Baylor College of Medicine
RECRUITING
Houston
Houston Research Institute
RECRUITING
Houston
Houston Research Institute - Texas Medical Center
RECRUITING
Houston
LinQ Research, LLC
RECRUITING
Katy
Houston Research Institute - Pasadena
RECRUITING
Pasadena
American Research Corporation - San Antonio
RECRUITING
San Antonio
Pinnacle Clinical Research - San Antonio
RECRUITING
San Antonio
Velocity Clinical Research - Waco
RECRUITING
Waco
Virginia
Richmond Institute for Veterans Research
RECRUITING
Richmond
Washington
GI Alliance - Washington Gastroenterology
RECRUITING
Tacoma
Contact Information
Primary
Patricia Mendez, MD
patricia.mendez@bostonpharmaceuticals.com
617-826-0300
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 42
Treatments
Experimental: Efimosfermin (Dose 1)
Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).
Experimental: Efimosfermin (Dose 2)
Participants will receive efimosfermin (Dose 2) Q4W.
Placebo_comparator: Placebo
Participants will receive placebo Q4W.
Related Therapeutic Areas
Sponsors
Leads: Boston Pharmaceuticals
Collaborators: GlaxoSmithKline