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 who are willing to give written consent and agree to follow the study procedures before joining.
• People with a body mass index (BMI) between 30 and 35 who have a specific level of liver scarring (called F3 fibrosis), confirmed by a liver scan or blood test within the past month, or by a previous liver biopsy.
• People with a BMI between 30 and 50 who have a more advanced level of liver scarring (called F4 fibrosis/cirrhosis), confirmed by a liver scan within the past month, or by a previous liver biopsy.
• People who are willing to have a liver biopsy during the screening period (if one has not already been done recently) and another biopsy at the end of the treatment period.
• People with cirrhosis who also meet a specific set of blood test results and health measurements showing their liver is still reasonably well-functioning, with no history of liver complications, no enlarged veins in the food pipe, and alcohol use below certain limits (confirm with trial site for exact values).
• People with high blood pressure whose blood pressure has been stable and well-controlled on the same medication for at least 2 months before screening.
• Women who are either unable to become pregnant (due to surgical sterilisation at least 6 months before screening, or being past menopause), or who are using an effective form of contraception such as hormonal contraception, an intrauterine device, or another approved method.
• People who are willing and able to attend all required study visits within the timeframes set by the study.

Who may not be able to join:

• People who have previously had weight-loss (bariatric) surgery, unless they had a gastric band that was removed more than 3 years ago.
• People with severe or decompensated cirrhosis, meaning the liver has stopped working properly, or those who have a history of complications such as confusion caused by liver disease (encephalopathy), fluid in the abdomen (ascites), yellowing of the skin (jaundice), or bleeding from enlarged veins.
• People who have liver cancer (hepatocellular carcinoma).
• People whose blood test results show certain markers of poor liver function falling outside required ranges (confirm with trial site for exact values).
• People with another cause of liver disease, including heavy alcohol use, hepatitis B or C, autoimmune hepatitis, or certain inherited liver conditions such as haemochromatosis or Wilson's disease.
• People currently undergoing treatment for cancer, including chemotherapy, radiotherapy, or hormone therapy.
• People who are HIV positive.
• People who have had a serious heart or circulatory event in the past 6 months, such as a heart attack, stroke, chest pain from heart disease (angina), or a mini-stroke (TIA).
• People with severe long-term breathing problems.
• People with severe long-term heart failure (classified as Grade III or IV).
• Women who are pregnant or breastfeeding.
• People who are already taking part in another clinical trial at the same time.
• People who have had a problem with drug misuse in the past year.
• People who are not medically suitable for weight-loss (bariatric) surgery for any reason.
• People who would require a type of bariatric surgery other than laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass, as those are the only two procedures permitted in this study.
• People with a history of cancer, unless they have been in remission for at least 5 years, or unless they were treated for certain types of skin cancer or cervical cancer that are considered cured.

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