Phase 1 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:

• You are between 18 and 70 years old (inclusive)
• Your Body Mass Index (BMI) is between 23 and 40 (a measure of body weight relative to height)
• You can be male or female
• You have been diagnosed with liver cirrhosis (scarring of the liver), confirmed by a previous liver biopsy, medical imaging, or blood tests
• Your liver disease is rated as moderately severe or severe, scoring between 7 and 15 on a standard liver disease grading scale called Child-Pugh (classes B or C)
• Your liver condition has been present for more than 6 months and has been stable, with no sudden worsening in the month before the study screening visit, and remains stable throughout the screening period

Who may not be able to join:

• You have a history of serious health conditions outside the liver that may be related to why you developed cirrhosis
• You have a history of a condition called cryoglobulinemia (an immune system problem affecting the blood)
• You have a severe or hard-to-treat build-up of fluid in your abdomen (called Grade 3 or refractory ascites)
• You have severe or hard-to-treat confusion caused by liver disease (refractory encephalopathy), or another significant brain or nervous system condition
• You have had bleeding from varicose veins in your stomach or food pipe (esophagus) in the past 6 months that has not been properly treated
• Your liver disease is caused by something other than fatty liver disease (fatty liver disease must be the main cause)
• You have other significant physical health problems that could interfere with the study or put you at unacceptable risk, as judged by the study doctor
• You currently have or have previously had liver cancer (hepatocellular carcinoma)
• You have had a procedure called TIPS (a shunt placed inside the liver to redirect blood flow)
• You have a condition where the liver is affecting the lungs or kidneys (hepatopulmonary or hepatorenal syndrome)
• You have a liver disease primarily caused by blocked bile flow (cholestatic liver disease)
• You have symptoms of a gallbladder condition called cholecystitis (confirm with trial site)
• You have a history of pancreas injury, inflammation of the pancreas (pancreatitis), or other pancreas problems
• You have previously had a liver transplant or are currently on a waiting list for one
• You currently show signs of an active infection
• You have a history of adrenal gland disease, or you take medication that affects a hormone system in the body called the hypothalamic-pituitary-adrenal (HPA) axis (confirm with trial site)
• You have a history of significant bone disease, such as osteoporosis (weakening of the bones)
• The study doctor believes there is a high chance you may drop out of the study due to personal or social circumstances
• You have a history of or currently misuse drugs
• You are currently taking part in another clinical trial, or have done so recently (within 30 days or longer, depending on the drug involved)
• You have previously taken a drug called efimosfermin alfa
• Certain blood test results are outside the allowed range — specifically, liver enzyme levels (ALT and AST) or kidney function (eGFR) fall outside set limits (confirm exact values with trial site)
• A specific measurement of your heart's electrical activity (called QTcF interval) is above 480 milliseconds on a heart tracing (ECG) at screening
• If you are in the group with alcohol-related fatty liver disease, you are at significant risk of alcohol withdrawal symptoms

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