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A pivotal clinical study to investigate the safety and efficacy of efimosfermin alfa injection in participants with biopsyconfirmed F2- or F3-stage MASH (BOS-580-301)
EU CTIS ID: 2025-523675-39-00
What this study is testing
Week 52 Analysis: To determine the effect of efimosfermin compared to placebo on histologic resolution of MASH and improvement in fibrosis after 52 weeks treatment. Month 48 Analysis To determine the time to a composite clinical outcome following treatment with efimosfermin compared to placebo after up to 48 months treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 enrolment.
- 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.
- 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 decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
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 enrolment.
- 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.
- 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 decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
- Current or history of excessive alcohol intake for >=3 months within the 12-month period prior to Screening.
- ALT or AST >=5*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 <=20% of total bilirubin; otherwise, the individual will be excluded.
- 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 Study Medical Monitor.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Singapore
- China
- Mexico
- Turkey
- Australia
- Argentina
- Korea, Republic of
- India
- United Kingdom
- Saudi Arabia
- Brazil
- Taiwan
- Chile
- New Zealand
- Canada
- Israel
- Hong Kong
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Singapore; China; Mexico; Turkey; Australia and 13 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 EU CTIS; the study team decides eligibility.