Clinical trial NCT06920043: A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) MASH
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metabolic Dysfunction-Associated Steatohepatitis
Keywords: Fibroblast growth factor
Stage 4 fibrosis
Compensated Cirrhosis
Lead sponsor: Boston Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of participants with treatment emergent adverse events (TEAEs)
timeFrame: From Day 1 to 100 weeks
Secondary outcomes:
measure: Serum concentrations of efimosfermin
timeFrame: Up to Week 21
measure: Maximum serum drug concentration (Cmax) of efimosfermin
timeFrame: Up to Week 21
measure: Area under the serum concentration-time curve (AUC) of efimosfermin
timeFrame: Up to Week 21
measure: Average serum drug concentration (Cavg) of efimosfermin
timeFrame: Up to Week 21
measure: Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin
timeFrame: Up to Week 21
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Liver Health - Chandler
state: Arizona
city: Peoria
country: United States
facility: Arizona Liver Health - Peoria
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
state: Arizona
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: Lancaster
country: United States
facility: OM Research LLC
state: California
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia PC
state: California
city: Orange
country: United States
facility: Knowledge Research Center
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Santa Maria
country: United States
facility: Santa Maria Gastroenterology Center
state: California
city: Maitland
country: United States
facility: ClinCloud Research - Maitland
state: Florida
city: Miami
country: United States
facility: Advanced Clinical Research of Miami
state: Florida
city: Columbus
country: United States
facility: Centricity Research - Columbus
state: Georgia
city: Baltimore
country: United States
facility: Mercy Medical Center - Baltimore, Maryland
state: Maryland
city: Flowood
country: United States
facility: Gastrointestinal Associates and Endoscopy Center, PA - Flowood
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Tandem Intermediate, LLC - New York
state: New York
city: Fayetteville
country: United States
facility: Coastal Research Institute, LLC
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Austin
country: United States
facility: IMA Clinical Research - Austin, TX
state: Texas
city: Austin
country: United States
facility: American Research Corporation - Austin, TX
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research - Austin, TX
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Georgetown
country: United States
facility: Pinnacle Clinical Research - Georgetown
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Research Institute
state: Texas
city: Katy
country: United States
facility: LinQ Research, LLC
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research - San Antonio
state: Texas
city: Waco
country: United States
facility: Velocity Clinical Research - Waco
state: Texas
city: Richmond
country: United States
facility: Richmond Institute for Veterans Research
state: Virginia
city: Tacoma
country: United States
facility: GI Alliance - Washington Gastroenterology
state: Washington
Study officials:
References: