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

Phase 2

Recruiting

• Conditions: Metabolic Dysfunction-Associated Steatohepatitis
• Interventions: Drug: Efimosfermin; Drug: Placebo

• Registration Number: NCT06920043
• Lead Sponsor: Boston Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-04-02
• Study Start: 2025-04-09
• Study First Posted: 2025-04-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efimosfermin (Dose 1)	Efimosfermin	Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).
Efimosfermin (Dose 2)	Efimosfermin	Participants will receive efimosfermin (Dose 2) Q4W.
Placebo	Placebo	Participants will receive placebo Q4W.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events (TEAEs)	From Day 1 to 100 weeks	To assess the effects of efimosfermin on safety and tolerability.

Secondary Outcome Measures

Name	Time	Method
Serum concentrations of efimosfermin	Up to Week 21	To assess the steady-state PK of efimosfermin.
Maximum serum drug concentration (Cmax) of efimosfermin	Up to Week 21	To assess the steady-state PK of efimosfermin.
Area under the serum concentration-time curve (AUC) of efimosfermin	Up to Week 21	To assess the steady-state PK of efimosfermin.
Average serum drug concentration (Cavg) of efimosfermin	Up to Week 21	To assess the steady-state PK of efimosfermin.
Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin	Up to Week 21	To assess the steady-state PK of efimosfermin.

Trial Locations

Locations (33)

Arizona Liver Health - Chandler; 🇺🇸 Chandler, Arizona, United States

Arizona Liver Health - Peoria; 🇺🇸 Peoria, Arizona, United States

The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson; 🇺🇸 Tucson, Arizona, United States

Fresno Clinical Research Center; 🇺🇸 Fresno, California, United States

OM Research LLC; 🇺🇸 Lancaster, California, United States

Gastrointestinal Specialists of Georgia PC; 🇺🇸 Marietta, California, United States

Knowledge Research Center; 🇺🇸 Orange, California, United States

California Liver Research Institute; 🇺🇸 Pasadena, California, United States

Inland Empire Liver Foundation; 🇺🇸 Rialto, California, United States

Santa Maria Gastroenterology Center; 🇺🇸 Santa Maria, California, United States

ClinCloud Research - Maitland; 🇺🇸 Maitland, Florida, United States

Advanced Clinical Research of Miami; 🇺🇸 Miami, Florida, United States

Centricity Research - Columbus; 🇺🇸 Columbus, Georgia, United States

Mercy Medical Center - Baltimore, Maryland; 🇺🇸 Baltimore, Maryland, United States

Gastrointestinal Associates and Endoscopy Center, PA - Flowood; 🇺🇸 Flowood, Mississippi, United States

Kansas City Research Institute; 🇺🇸 Kansas City, Missouri, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Tandem Intermediate, LLC - New York; 🇺🇸 New York, New York, United States

Coastal Research Institute, LLC; 🇺🇸 Fayetteville, North Carolina, United States

M3 Wake Research, Inc; 🇺🇸 Raleigh, North Carolina, United States

IMA Clinical Research - Austin, TX; 🇺🇸 Austin, Texas, United States

American Research Corporation - Austin, TX; 🇺🇸 Austin, Texas, United States

Pinnacle Clinical Research - Austin, TX; 🇺🇸 Austin, Texas, United States

The Liver Institute at Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States

Pinnacle Clinical Research - Georgetown; 🇺🇸 Georgetown, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Houston Research Institute; 🇺🇸 Houston, Texas, United States

LinQ Research, LLC; 🇺🇸 Katy, Texas, United States

American Research Corporation - San Antonio; 🇺🇸 San Antonio, Texas, United States

Pinnacle Clinical Research - San Antonio; 🇺🇸 San Antonio, Texas, United States

Velocity Clinical Research - Waco; 🇺🇸 Waco, Texas, United States

Richmond Institute for Veterans Research; 🇺🇸 Richmond, Virginia, United States

GI Alliance - Washington Gastroenterology; 🇺🇸 Tacoma, Washington, United States