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:

• Adults between 18 and 70 years old
• People who can understand written and spoken English and/or Spanish
• People in the "insulin sensitive" group (Group IS) with a body mass index (a measure of body weight relative to height) between 18 and 25
• People in the "insulin resistant" group (Group IR) with a body mass index between 30 and 45
• People in Group IS whose blood test results show low fasting insulin, normal blood sugar levels, and no signs of liver scarring (confirm with trial site for exact values)
• People in Group IR whose blood test results show higher fasting insulin levels, plus at least one sign of prediabetes or insulin resistance (confirm with trial site for exact values)

Who may not be able to join:

• People who are unable to give informed consent in English or Spanish
• People whose blood pressure or resting heart rate falls outside certain safe ranges at the screening visit
• People whose blood tests show abnormal liver function or electrolyte levels that the trial doctor considers potentially serious
• People whose blood tests show signs of diabetes (such as a high HbA1c or high fasting blood sugar)
• Women who are pregnant, currently breastfeeding, or who test positive on a pregnancy test at screening
• People with a personal history of diabetes (as defined by the American Diabetes Association)
• People who have had gestational diabetes (diabetes during pregnancy) within the past 5 years
• People who have used most blood sugar-lowering medications (other than metformin) in the 90 days before screening — this includes medications such as GLP-1 receptor agonists, SGLT2 inhibitors, sulfonylureas, and insulin, among others
• People with a clinical concern for complete insulin deficiency, such as type 1 diabetes or pancreatic disease
• People with a personal or close family history of inherited cholesterol or fat metabolism disorders (such as familial hypercholesterolemia)
• People who have used certain cholesterol-lowering medications (such as fibrates, high-dose prescription omega-3s, or high-dose niacin) within 14 days before screening
• People with a known history of significant heart disease (note: uncomplicated high blood pressure alone does not automatically exclude someone)
• People with severe liver disease or advanced liver scarring or cirrhosis
• People with certain psychiatric conditions that have been unstable within the past year, or who use certain antipsychotic medications linked to significant weight gain or metabolic problems (such as clozapine or olanzapine)
• People with a history of blood clots in the veins (such as deep vein thrombosis or pulmonary embolism), or who require blood-thinning medications
• People with bleeding disorders or significant anaemia
• People with an active cancer, or a hormone-producing benign tumour (certain exceptions apply — confirm with trial site)
• People for whom the trial doctor has concerns about the risk of fluid overload due to medications or heart, liver, or kidney problems
• People who have used high-dose oral or injected corticosteroids (steroid medications, above the equivalent of 5 mg prednisone daily) for more than 3 days within the past 30 days (topical or inhaled steroids are generally permitted)
• People who have had certain types of weight-loss surgery, including Roux-en-Y gastric bypass or biliopancreatic diversion at any time, or a lap band or sleeve gastrectomy within the past 6 months
• People whose alcohol intake exceeds 14 standard drinks per week (for males) or 7 standard drinks per week (for females)
• People who smoke daily or average at least one cigarette per day, or who vape nicotine more than one day per week
• People with a clinical concern about use of illicit drugs (other than marijuana or lawfully prescribed medications), based on self-report, medical records, or a urine drug test at screening
• People who have had a fever-causing illness within 30 days of screening
• People with any other condition, disease, or abnormal test result that the investigator believes would put them at unacceptable risk or interfere with the study results
• People with a known allergy or sensitivity to any ingredient in the study medications, including soy, cow's dairy, or gluten, as well as allergies to materials used in blood draws, plastics, adhesives, or silicone
• People who follow dietary restrictions (such as vegan, kosher, or halal diets) that prevent them from consuming gelatin, which is present in the capsules used in this trial
• People who are currently enrolled in, or have been enrolled in, another clinical trial of an investigational drug or treatment within 6 months before screening, or within 5 half-lives of that investigational treatment, whichever is longer (exceptions may apply for people who have previously participated in studies led by the principal investigator — confirm with trial site)

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