Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from the 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 of Chinese background aged between 18 and 75 years
• People who have been diagnosed with non-alcoholic fatty liver disease (a condition where too much fat builds up in the liver), confirmed by a specific type of liver fat scan (MRI) showing fat levels of 10% or more, done recently or within the past month
• People who have at least one of the following metabolic (body chemistry) risk factors: being overweight or having a large waist measurement; having higher-than-normal blood sugar levels, a diagnosis of type 2 diabetes, or signs of insulin resistance; having higher-than-normal blood pressure or currently taking blood pressure medication; having abnormal cholesterol or triglyceride (blood fat) levels, or currently taking cholesterol-lowering medication
• People whose weight has been stable (changed by no more than 5%) in the six weeks before joining
• People who are not planning to have children within three months of signing the consent form and who are willing to use effective contraception during that time
• People who are willing to take part voluntarily, able to give written consent, and able to follow the trial procedures

Who may not be able to join:

• People who have cirrhosis (severe liver scarring) or results from scans, blood tests, or physical examination suggesting cirrhosis or an enlarged spleen, or a liver biopsy in the past two years showing advanced liver scarring
• People with a history of any cancer, or who have had or are planning a liver transplant
• People with a history of any liver disease other than non-alcoholic fatty liver disease, such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, or several other specific liver conditions
• People with any type of diabetes other than type 2 diabetes, or people currently using or planning to use insulin, thiazolidinediones, or GLP-1 medications (a type of diabetes or weight-loss drug)
• People with other serious, worsening, or poorly controlled conditions (beyond type 2 diabetes, high blood pressure, or abnormal cholesterol) that the trial doctor considers would increase the risk of taking part
• People who have previously had weight-loss surgery, are planning weight-loss procedures during the trial, or have recently made significant changes to their exercise or diet
• People who have had a bone injury, fracture, or bone-related surgery within the two months before screening
• People with a personal or family history of a heart rhythm condition called long QT syndrome, or whose heart rhythm measurements (QTcF) on an ECG are above the accepted threshold for their sex
• People who are allergic to the trial drug (B1344) or its ingredients, or who have had severe allergic reactions to other biological medicines
• People who have taken certain medications known to affect the liver (such as amiodarone, methotrexate, steroids, or others listed in the trial protocol) for more than two weeks in the 12 months before screening
• People whose current or planned other medications do not meet trial requirements, or who cannot keep their medication doses stable throughout the trial
• People who have previously used a type of drug called an FGF-21 analog or FGFR1 agonist (confirm with trial site if unsure whether this applies)
• People whose screening blood or urine test results fall outside the trial's accepted ranges — including abnormal liver enzyme levels, reduced kidney function, low red blood cell levels, poorly controlled blood sugar, abnormal blood clotting, low platelet count, low bone density, abnormal blood pressure or heart rate, very high triglycerides, or positive results for hepatitis B, hepatitis C, HIV, or syphilis
• People who drink alcohol heavily, who have consumed 14 or more standard alcohol units per week in the three months before screening, who test positive for alcohol at screening, or who are unable to avoid alcohol from the first dose until the end of the trial
• People who have been consuming very large amounts of tea, coffee, or caffeinated drinks (more than 8 cups per day) in the three months before screening, or who have had any caffeinated food or drink in the 48 hours before the first dose
• People who have donated blood, lost a significant amount of blood, received a blood transfusion, or used blood products in the three months before screening, or who plan to donate blood during the trial
• People with a strong fear of needles or blood, a history of frequently fainting when standing up, or who are unable to tolerate having blood taken from a vein
• People with a history of drug misuse, or who test positive for illicit drugs at screening
• People who smoke more than five cigarettes per day and are unable to quit completely during the trial
• Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial
• People with skin conditions or physical features on the abdomen that would make injections under the skin difficult, or who have tattoos or scars covering more than half of the abdominal area
• People who have taken part in another clinical trial and received an experimental treatment within the past three months
• People who have a medical reason they cannot have an MRI scan, or who are unable to cooperate with MRI examinations
• People considered unsuitable for any other reason, as determined by the trial doctor

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