Metabolic Dysfunction-Associated Steatohepatitis study: Efimosfermin
Official title A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
ClinicalTrials.gov ID: NCT06920043
What this study is testing
What is Efimosfermin?
An investigational subcutaneous injectable medicine being studied as a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH). It is designed to activate fibroblast growth factor 21 (FGF21) pathways that help regulate metabolism and liver fat.
Also referred to as BOS-580.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to check if the drug is safe and to see if it helps improve liver health.
- Who it's for
- People who have been diagnosed with MASH and have advanced liver scarring (cirrhosis) that is currently stable.
- What's involved
- Participants will receive the study drug and undergo medical tests to monitor their liver function and how their body processes the medication.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 may apply.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Mesa, Arizona, United States
- Tucson, Arizona, United States
- Fresno, California, United States
- Lancaster, California, United States
- Pasadena, California, United States
- Rialto, California, United States
- Santa Maria, California, United States
- Miami, Florida, United States
- Viera, Florida, United States
- Marietta, Georgia, United States
- Baltimore, Maryland, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Fayetteville, North Carolina, United States
- Wilson, North Carolina, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Georgetown, Texas, United States
- Houston, Texas, United States
+ 5 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Mesa, Arizona, United States; Tucson, Arizona, United States; Fresno, California, United States; Lancaster, California, United States; Pasadena, California, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.