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New treatment option for Metabolic Dysfunction-Associated Steatohepatitis
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?
Efimosfermin is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for metabolic dysfunction-associated steatohepatitis.
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
- 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.
- 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's taking place
- 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 compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.