Phase 2 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 able to communicate clearly with the research team and can legally sign a consent form on their own behalf.
• People aged between 21 and 75 years.
• People who have been diagnosed with type 2 diabetes, based on their medical history, diabetes medications they take, or blood test results.
• People whose blood sugar control (measured by a test called HbA1c) is at or below 9.5%, whether managed by diet alone or by certain diabetes medications taken at a stable dose for at least 2 months (or 6 months for a specific type called GLP-1 receptor agonists, with stable body weight in the prior 3 months).
• People whose blood test results fall within acceptable ranges for red blood cells, white blood cells, platelets, liver function, kidney function, and certain proteins in the blood (confirm specific values with the trial site).

Who may not be able to join:

• People with a history of drinking alcohol above certain daily limits (more than 20g per day for women or more than 30g per day for men), as assessed by doctors, self-report, family reports, and a standardised questionnaire.
• People who have been taking long-term medications known to affect blood sugar levels, unless those medications have been at a stable dose for at least 4 weeks before starting the trial.
• People currently using certain medications that can cause fat to build up in the liver, such as estrogen or hormone replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, high-dose oral steroids, or chloroquine.
• People currently using high-dose vitamin E (800 IU or more per day), pioglitazone, or any medication approved by the FDA specifically for the liver condition being studied.
• People who have a chronic liver disease caused by something other than the condition being studied, such as hepatitis B or C infection, autoimmune liver disease, certain inherited conditions, or a history of liver cancer.
• People who have other medical conditions known to cause a fatty liver.
• People who have signs of advanced liver scarring (cirrhosis) or serious liver complications, such as a history of fluid build-up in the abdomen, bleeding from veins in the food pipe, or episodes of confusion caused by liver failure.
• People who have previously had, or are scheduled to have, certain stomach or bowel surgeries, such as weight-loss surgery involving the stomach or intestines.
• People with a history of significant exposure to certain industrial chemicals, such as carbon tetrachloride.
• People who have received nutrition delivered directly into their veins (intravenous feeding) within the past 6 months.
• People who have any form of diabetes other than type 2 diabetes.
• People with a significant history of heart disease, including heart failure, unstable chest pain, a heart attack, or a procedure on the heart arteries within the past 6 months, or current unstable heart rhythm problems.
• People with poorly controlled high blood pressure, circulation problems in the legs, a stroke or mini-stroke within the past 6 months, significant lung disease, or kidney disease with elevated kidney markers or significant protein in the urine.
• Women who are pregnant, breastfeeding, or not at least two years past menopause, unless using a highly effective form of contraception as specified by the trial (this must be continued for at least one menstrual cycle after the trial ends).
• People with a history of cancer in the past 5 years, or an active cancer, with the exception of certain minor skin cancers that have been fully resolved.
• People with a history of bladder disease or blood in the urine, unless caused by a recent urinary tract infection.
• People with blood clotting disorders or who are currently taking blood-thinning medications.
• People who the research team considers, for any other reason, to be unsuitable candidates for the study.

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