RECRUITING

A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) MASH

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2025-04-09
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06920043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to understand and sign a written informed consent form (ICF)
  2. * Age 18 through 75 years at enrollment
  3. * History or presence of 2 or more of the 5 components of metabolic syndrome
  4. * Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
  5. * Other inclusion criteria may apply.
  1. * Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
  2. * History of type 1 diabetes
  3. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
  4. * Other exclusion criteria may apply.

Contacts and Locations

Study Contact

Patricia Mendez, MD
CONTACT
617-826-0300
patricia.mendez@bostonpharmaceuticals.com

Study Locations (Sites)

Arizona Liver Health - Chandler
Chandler, Arizona, 85224
United States
Arizona Liver Health - Peoria
Peoria, Arizona, 85381
United States
The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
Tucson, Arizona, 85712
United States
Fresno Clinical Research Center
Fresno, California, 93720
United States
OM Research LLC
Lancaster, California, 93534
United States
Gastrointestinal Specialists of Georgia PC
Marietta, California, 30060
United States
Knowledge Research Center
Orange, California, 92868
United States
California Liver Research Institute
Pasadena, California, 91105
United States
Inland Empire Liver Foundation
Rialto, California, 92377
United States
Santa Maria Gastroenterology Center
Santa Maria, California, 93458
United States
ClinCloud Research - Maitland
Maitland, Florida, 32751
United States
Advanced Clinical Research of Miami
Miami, Florida, 33155
United States
Centricity Research - Columbus
Columbus, Georgia, 31904
United States
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, 21202
United States
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood, Mississippi, 39232
United States
Kansas City Research Institute
Kansas City, Missouri, 64131
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Tandem Intermediate, LLC - New York
New York, New York, 10033
United States
Coastal Research Institute, LLC
Fayetteville, North Carolina, 28304
United States
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
United States
IMA Clinical Research - Austin, TX
Austin, Texas, 78745
United States
American Research Corporation - Austin, TX
Austin, Texas, 78757
United States
Pinnacle Clinical Research - Austin, TX
Austin, Texas, 78757
United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
United States
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, 78626
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Research Institute
Houston, Texas, 77079
United States
LinQ Research, LLC
Katy, Texas, 77494
United States
American Research Corporation - San Antonio
San Antonio, Texas, 78215
United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
United States
Velocity Clinical Research - Waco
Waco, Texas, 76710
United States
Richmond Institute for Veterans Research
Richmond, Virginia, 23249
United States
GI Alliance - Washington Gastroenterology
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Boston Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-09
Study Completion Date2027-11

Study Record Updates

Study Start Date2025-04-09
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Fibroblast growth factor
  • Stage 4 fibrosis
  • Compensated Cirrhosis

Additional Relevant MeSH Terms

  • Metabolic Dysfunction-Associated Steatohepatitis