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

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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Metabolic Dysfunction-Associated Steatohepatitis
Intervention / Treatment

-

Contacts and Locations

Chandler

Arizona Liver Health - Chandler, Chandler, Arizona, United States, 85224

Peoria

Arizona Liver Health - Peoria, Peoria, Arizona, United States, 85381

Tucson

The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson, Tucson, Arizona, United States, 85712

Fresno

Fresno Clinical Research Center, Fresno, California, United States, 93720

Lancaster

OM Research LLC, Lancaster, California, United States, 93534

Marietta

Gastrointestinal Specialists of Georgia PC, Marietta, California, United States, 30060

Orange

Knowledge Research Center, Orange, California, United States, 92868

Pasadena

California Liver Research Institute, Pasadena, California, United States, 91105

Rialto

Inland Empire Liver Foundation, Rialto, California, United States, 92377

Santa Maria

Santa Maria Gastroenterology Center, Santa Maria, California, United States, 93458

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Pharmaceuticals,

Study Record Dates

2027-11