Non-alcoholic Fatty Liver Disease study: Efimosfermin Alfa
Official title A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
ClinicalTrials.gov ID: NCT07221188
What this study is testing
What is Efimosfermin Alfa?
An investigational medicine being studied as a potential treatment for non-alcoholic fatty liver disease (MASH) with fibrosis stage F2 or F3. It is designed to activate fibroblast growth factor 21 (FGF21) pathways that may help improve liver metabolism.
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 study aims to find out whether Efimosfermin Alfa is safe and well‑tolerated in participants with known or suspected MASH and liver fibrosis stage F2 or F3.
- Who it's for
- Adults who have been diagnosed with or are suspected of having MASH with liver scarring at stage F2 or F3.
- What's involved
- Participants will receive injections of Efimosfermin Alfa and will undergo safety monitoring, which may include clinic visits and routine lab tests.
- Phase 3: a large, late-stage study
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
- Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
- Age \>=18 through \<=75 years at enrolment
- History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
- History or presence of known or suspected MASH with evidence of fibrosis
You likely can't join if
- ALT or AST \>=5 × upper limit of normal (ULN)
- Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an...
- Serum albumin \<=3.5 grams per deciliter (g/dL)
- International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation.
- Alkaline phosphatase (ALP) \>=2 × ULN
- Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled...
See the full eligibility criteria
- Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
- Age \>=18 through \<=75 years at enrolment
- History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
- History or presence of known or suspected MASH with evidence of fibrosis
- ALT or AST \>=5 × upper limit of normal (ULN)
- Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is...
- Serum albumin \<=3.5 grams per deciliter (g/dL)
- International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and...
- Alkaline phosphatase (ALP) \>=2 × ULN
- Platelet (PLT) count \<140 000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor
- Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.
- Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)
- HbA1c \>=9.0%
- Model for End-Stage Liver Disease (MELD) 3.0 score \>=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)
- Phosphatidylethanol (PEth) \>=80 nanogram per milliliter (ng/mL) at Screening
- Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. Hepatitis C virus (HCV); d. Hepatitis D virus; or e. Hepatitis E virus.
- Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis, or any history or evidence of cirrhosis
- Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening
The study team makes the final eligibility decision.
Where it is enrolling
- Arcadia, California, United States
- Covina, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Santa Maria, California, United States
- Van Nuys, California, United States
- Boynton Beach, Florida, United States
- Cape Coral, Florida, United States
- Clermont, Florida, United States
- Doral, Florida, United States
- Fort Myers, Florida, United States
- Hialeah, Florida, United States
- Homestead, Florida, United States
- Inverness, Florida, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Lakeland, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
+ 35 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 Arcadia, California, United States; Covina, California, United States; Los Angeles, California, United States; San Diego, California, United States; Santa Maria, California, United States; Van Nuys, California, United States and 49 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.