Bupropion hydrochloride, Naltrexone hydrochloride for Obesity | Non-alcoholic fatty liver disease (MASLD) | Liver fibrosis

Inclusion criteria

• {"criterion_text":"- BMI > 27 kg/m2 and at least one cardiometabolic risk factor (type 2 diabetes, hypertension, dyslipidaemia) or BMI > 30"}
• {"criterion_text":"- Moderate to severe liver fibrosis (LSM >7.0 kPa and <13.6 kPa)"}
• {"criterion_text":"- Aged 18-75 years"}
• {"criterion_text":"- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- An insufficient comprehension of the Dutch language (spoken and written)"}
• {"criterion_text":"- Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose"}
• {"criterion_text":"- Known or suspected excessive alcohol consumption (>21 drinks/week for males or >14 drinks/week for females. One drink is equivalent to 10 grams of alcohol)"}
• {"criterion_text":"- Previous or planned (during the trial period) obesity treatment with surgery. However, previous interventions that, due to reversal or removal, do not have any influence on the patient’s weight, in the opinion of the investigator, are allowed"}
• {"criterion_text":"- Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient’s safety or ability to complete the study"}
• {"criterion_text":"- Female who is pregnant, breast-feeding or intends to become pregnant"}
• {"criterion_text":"- Participants with an established diagnosis of liver pathology like, but not limited to: Hepatitis B, Hepatitis C, Autoimmune hepatitis, Wilson’s disease, Hemochromatosis, Primary biliary cholangitis, Primary sclerosing cholangitis, Alcoholic liver disease"}
• {"criterion_text":"- History of liver transplant, or current placement on a liver transplant list"}
• {"criterion_text":"- History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding"}
• {"criterion_text":"- Participants with active HIV infection and/or treatment"}
• {"criterion_text":"- Participants with diagnosed malignancies with or without active treatment"}
• {"criterion_text":"- Participants with history or pre-existing renal disease (eGFR <30 mL/min/1.73 m2)"}
• {"criterion_text":"- Participants with corticosteroid induced diabetes (while still using corticosteroids)"}

Primary endpoints

• {"endpoint_text":"- Between-group difference in liver fibrosis during six months. Liver fibrosis will be measured as liver stiffness (kPa) by transient elastography (TE) (FibroScan®)","definition_or_measurement_approach":"Liver fibrosis measured as liver stiffness (kPa) by transient elastography (TE) (FibroScan®) from baseline to end of study over six months."}

Secondary endpoints

• {"endpoint_text":"- Liver steatosis (CAP score, FibroScan)","definition_or_measurement_approach":"Controlled Attenuation Parameter (CAP) score measured by FibroScan."}
• {"endpoint_text":"- Nutritional assessment: Body weight (kg), height (cm), waist circumference (cm), fat mass and lean body mass measured with bioelectrical impedance analysis (kg), grip strength (kg)","definition_or_measurement_approach":"Anthropometrics and body composition via bioelectrical impedance analysis; grip strength measured in kg."}
• {"endpoint_text":"- Cardiovascular risk factors: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apolipoprotein B (ApoB), apolipoprotein AI (ApoAI), lipoprotein (a), HbA1c, fasting blood glucose, fasting insulin and blood pressure, measured with routine lab procedures","definition_or_measurement_approach":"Laboratory measurements using routine lab procedures; blood pressure measured clinically."}
• {"endpoint_text":"- Other laboratory measurements, measured with routine lab procedures. Among others the following routine measurements will be done: creatinine, estimated GFR (eGFR), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), thrombocytes, haemoglobin (Hb), leukocytes, transferrin and ferritin, total iron binding capacity, apolipoprotein B48 (ApoB48), fibroblast growth factor 19 (FGF19) and 21 (FGF21), C-reactive protein (CRP), fibrosis-4 index score (Fib-4)","definition_or_measurement_approach":"Routine laboratory procedures for listed analytes; Fib-4 index calculated from lab values."}
• {"endpoint_text":"- Physical activity","definition_or_measurement_approach":"Not specified in CTIS record"}
• {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"Not specified in CTIS record"}
• {"endpoint_text":"- Patient satisfaction","definition_or_measurement_approach":"Not specified in CTIS record"}
• {"endpoint_text":"- Food intake and adherence to the dietary intervention","definition_or_measurement_approach":"Not specified in CTIS record"}
• {"endpoint_text":"- Demographic variables, drug use, smoking and drinking habits, (diabetes) medication use and compliance to the time restriction","definition_or_measurement_approach":"Collected by questionnaire or routine data; specific methods not detailed in CTIS record"}

Netherlands

Earliest CTIS Part Ii Submission Date

27-01-2025

Latest Decision Or Authorization Date

16-10-2025

Processing Time Days

262

Number Of Sites

1

Number Of Participants

70

Primary sponsor

Full Name

Sint Franciscus Vlietland Groep Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands