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New treatment option for Non-alcoholic Fatty Liver Disease
Official title A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
ClinicalTrials.gov ID: NCT07221227
What this study is testing
What is Efimosfermin alfa?
Efimosfermin alfa is an investigational medicine, being studied as a potential treatment for non-alcoholic fatty liver disease.
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 assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 that must be obtained prior to the initiation of study procedures
- Age \>=18 and \<=75 years at enrollment
- History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
- Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist
You likely can't join if
- Contraindication or ineligibility for percutaneous liver biopsy
- ALT or AST \>=5 x upper limit of normal (ULN)
- Total bilirubin \>=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. Individuals receiving chronic anticoagulant treatment with higher...
- Alkaline phosphatase (ALP) \>=2\ ULN
See the full eligibility criteria
- Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
- Age \>=18 and \<=75 years at enrollment
- History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
- Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist
- Contraindication or ineligibility for percutaneous liver biopsy
- ALT or AST \>=5 x upper limit of normal (ULN)
- Total bilirubin \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of \>=1.3 mg/dL and direct bilirubin 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)
- Glycated hemoglobin \>=9.0%
- Model for End-Stage Liver Disease score \>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
- Phosphatidyl ethanol (PEth) \>=80 ng/mL at Screening
- Evidence of infection with any of the following:
- Human immunodeficiency virus;
- Hepatitis B virus (detectable HBsAg at Screening);
- Hepatitis C virus (HCV);
- 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 on screening liver biopsy; or...
- 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's taking place
- Arcadia, California, United States
- Covina, California, United States
- Los Angeles, California, United States
- Santa Maria, California, United States
- Van Nuys, California, United States
- Boynton Beach, Florida, United States
- Cape Coral, Florida, United States
- Hialeah, 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
- Ocala, Florida, United States
- Palmetto Bay, Florida, United States
- Topeka, Kansas, United States
- Springfield, Missouri, United States
- St Louis, Missouri, United States
+ 20 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 Arcadia, California, United States; Covina, California, United States; Los Angeles, California, United States; Santa Maria, California, United States; Van Nuys, California, United States; Boynton Beach, Florida, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.