Phase 4 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are considered a suitable candidate for general anaesthesia
• People who qualify for weight loss (metabolic) surgery — specifically a gastric bypass (RYGB) or sleeve gastrectomy (SG) — based on current international guidelines
• People who have insurance coverage for metabolic surgery (requirements may differ by country)
• People who are between 18 and 75 years old at the time of signing the consent form
• People with a BMI between 35 and 70 kg/m² at the first study visit
• People with a liver scarring blood test score (FIB-4) of 1.3 or higher
• People with at least one test result suggesting significant liver scarring, measured by one of several liver stiffness imaging or blood tests (confirm specific test types and cut-off values with the trial site)
• People with or without type 2 diabetes — those with type 2 diabetes must have been on a stable diabetes medication dose for at least 3 months before joining, with blood sugar control (HbA1c) at or below 12%, and must not be taking semaglutide, tirzepatide, or liraglutide
• People whose weight has been stable in the 6 months before the first study visit, with no more than 10% weight loss during that period
• People who are willing and able to take part in the study, understand what it involves, and agree to its requirements — including up to two liver biopsies over the course of the study
• Women of childbearing potential who have a negative pregnancy test at the first and randomisation visits
• Women of childbearing age who agree to use a reliable method of contraception throughout the 2-year study period

Who may not be able to join:

• People with a known history of other chronic liver diseases, including hepatitis B, hepatitis C, autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, alpha-1-antitrypsin deficiency, haemochromatosis, drug-induced liver disease, bile duct blockage, or suspected or confirmed liver cancer
• People whose weight changed by more than 10% in the 6 months before the first study visit or before a historical liver biopsy
• People who have taken semaglutide, tirzepatide, or liraglutide within 90 days before the first study visit, unless they were on a low dose and lost less than 10% of their body weight since starting the medication (confirm with trial site)
• People with type 1 diabetes or autoimmune diabetes
• People with a known HIV infection
• People who have previously had any type of bariatric or weight loss surgery — though people who had a gastric band or intragastric balloon that was fully reversed and removed at least 3 months before the first study visit may be eligible (confirm with trial site)
• People who have had prior complex surgery on the oesophagus, stomach, bile ducts, or related areas, including anti-reflux procedures
• People who have had any surgery requiring general anaesthesia within 1 month before signing the consent form
• People who have had a solid organ transplant
• People with severe lung disease (specifically, lung function below 50% of the expected level)
• People with significant heart or artery disease who are planned to have heart or blood vessel surgery within the next 12 months
• People with severe heart or lung disease placing them in the highest-risk surgical categories (ASA Class IV or V)
• People classified as having the most severe level of heart failure (New York Heart Association Class IV)
• People whose heart pumping function is below 25% at the time of screening
• People who have had a heart attack, unstable chest pain, stroke, heart surgery, or a coronary stent placed within the past 6 months
• People with severe kidney disease (eGFR below 30 mL/min/1.73 m²) or who are on dialysis
• People with a large hiatal hernia (greater than 7 cm)
• People with Crohn's disease
• People with certain psychiatric conditions — including dementia, active psychosis, severe depression requiring three or more medications, a history of suicide attempts, or active alcohol or substance misuse within the past 12 months — that in the investigators' opinion would make weight loss surgery unsafe
• People who are pregnant, planning to become pregnant, or not using adequate contraception
• People who are breastfeeding
• People diagnosed with cancer within the past 3 years (except certain common skin cancers)
• People with significant anaemia (haemoglobin below 9 g/dL)
• People on full therapeutic doses of blood-thinning medications such as warfarin or direct oral anticoagulants (DOACs)
• People with a known history of blood clotting disorders, including pulmonary embolism or deep vein thrombosis
• People whose life expectancy is estimated to be less than 3 years
• People who have used an investigational (experimental) treatment within 3 months before signing the consent form
• People with a history of pancreatic cancer
• People who had acute pancreatitis within 180 days before screening
• People with a history or current diagnosis of chronic pancreatitis
• People with a concerning thyroid nodule
• People with uncontrolled thyroid disease, unless their thyroid hormone levels are normal or their treatment dose has been stable for at least 3 months (confirm with trial site)
• People with a personal or family history of medullary thyroid cancer, or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• People with a history or current evidence of fluid build-up in the abdomen (ascites) or related infections that required treatment — though a very small amount of fluid seen only on imaging, with no other signs of liver complications, is not automatically excluded (confirm with trial site)
• People with a history or current evidence of confusion or brain problems caused by liver disease (hepatic encephalopathy)
• People with a history or current evidence of bleeding from enlarged veins in the oesophagus or stomach (variceal bleeding)
• People with a history or current evidence of blood clots in the portal or splenic veins
• People with a history of significant alcohol use — defined as more than 14 standard drinks per week for women or more than 21 per week for men — for more than 3 consecutive months within the past year
• People who have taken certain medications known to affect liver fat (such as systemic steroids, methotrexate, tamoxifen, valproic acid, amiodarone, or tetracycline) for more than 14 consecutive days in the 3 months before the first study visit
• People with certain liver enzyme levels (ALT, AST, or alkaline phosphatase) above 200 U/L
• People with recurring severe low blood sugar episodes or an inability to recognise low blood sugar (hypoglycaemic unawareness)
• People for whom a liver biopsy cannot be safely performed
• People with any other condition or serious illness that, in the investigator's judgement, would place them at undue risk by participating
• People who are unable to understand the risks, benefits, and requirements of the study
• People who do not have the capacity to give informed consent
• People who plan to move to a different country within the next 24 months
• People with a known or suspected allergy to semaglutide, tirzepatide, liraglutide, or related products
• People who previously joined and were randomised in this trial but did not proceed
• People who were hospitalised due to COVID-19 within 2 months before screening
• People with a platelet count below 80,000
• People with an INR (a blood clotting measure) above 1.7
• People with a Child-Pugh score of B or C (a measure of liver disease severity)
• People with a MELD score of 15 or higher (another measure of liver disease severity)
• People whose endoscopy shows enlarged veins (varices) in the oesophagus or stomach, or more than mild signs of pressure-related stomach changes
• People whose liver ultrasound shows signs of significant high pressure in the liver's blood supply (portal hypertension), based on specific measurements (confirm details with trial site)
• People whose abdominal scans show large abnormal blood vessel connections or fluid in the abdomen
• People with a specific liver pressure measurement (HVPG) of 12 mmHg or higher, if this test has been done
• People whose liver biopsy results show no liver scarring (F0), or fall into certain other categories based on the specific pattern and severity of liver disease — the trial site will assess this based on biopsy results (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.