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 65 years old
• People with a body mass index (a measure of weight relative to height) between 30 and 45
• People who can read and speak English and/or Spanish
• People who are able to have their initial blood tests done and get started in the study within 60 days of being found eligible
• People who have a liver condition called metabolic dysfunction-associated steatotic liver disease (a type of fat buildup in the liver), confirmed by a specific painless scan, with a mild to moderate level of fat (S1–S3) and no more than moderate scarring (F0–F2)
• People who show signs that their body is not responding well to insulin, based on any of the following: blood sugar levels in the prediabetes range (HbA1c of 5.7–6.4%, or fasting blood sugar of 100–125 mg/dL), a specific insulin resistance score of 2.73 or higher, or a fasting insulin level of 13 or above
• People who have given written agreement to participate, in English or Spanish, before any study procedures begin

Who may not be able to join:

• People who are not able to give consent in English or Spanish
• People who lost 5% or more of their body weight in the 3 months before screening
• People with blood pressure that is too low or too high (below 90/60 or above 160/100 mmHg), even if being treated for it
• People with a resting heart rate below 55 or at or above 110 beats per minute
• People with an abnormal heart tracing (ECG) at screening or on a recent record
• People whose blood tests show they have diabetes (HbA1c of 6.5% or higher, or fasting blood sugar of 126 mg/dL or higher)
• Women who are pregnant, as confirmed by a pregnancy blood test
• Women who are currently breastfeeding
• People with significant liver enzyme abnormalities or elevated bilirubin levels on blood tests
• People with very high fasting triglyceride (a type of blood fat) levels above 500 mg/dL
• People with significantly abnormal salt and mineral levels in the blood, as judged by the study doctor
• People whose kidney function test results fall below a certain level (confirm with trial site)
• People with low red blood cell counts, low white blood cell counts, or low platelet counts on blood tests
• People with uric acid levels above the normal range
• People with a known or past history of diabetes (including gestational diabetes within the last 5 years)
• People who have used diabetes medications other than metformin in the 90 days before screening
• People where the treating doctor has concerns about a complete inability to produce insulin (such as type 1 diabetes or certain pancreatic conditions)
• People with known inherited conditions affecting cholesterol or fat in the blood
• People who have used certain cholesterol-related medications (fibrates, high-dose prescription omega-3s, or high-dose niacin) in the 90 days before screening
• People with a known history of pancreatic disease, including cancer, inflammation, or surgical removal of the pancreas
• People with a known history of heart disease, including heart attacks, strokes, blocked arteries, heart rhythm problems, heart failure, significant heart valve disease, or high blood pressure in the lungs
• People with known moderate-to-severe chronic kidney disease
• People with known liver disease beyond mild-to-moderate fatty liver, including advanced scarring, cirrhosis, autoimmune liver conditions, bile duct disorders, chronic liver infections, liver cancer, or certain storage disorders
• People with a known history of gout
• People with known chronic infection with hepatitis B, hepatitis C, or HIV
• People with conditions that affect how the gut absorbs nutrients
• People with an active seizure disorder, including those whose seizures are controlled with medication
• People with psychiatric conditions that have been poorly controlled within the past year, or who require certain psychiatric medications associated with significant weight gain or metabolic problems (confirm with trial site for specific medications)
• People with a known condition called G6PD deficiency (a red blood cell enzyme deficiency)
• People with other significant hormonal or glandular conditions
• People with a history of blood clots in the veins or lungs, or who need blood-thinning medication
• People with active cancer, or hormonally active non-cancerous tumours (with some exceptions, confirm with trial site)
• People where the study doctor has concerns about an elevated risk of low blood pressure or fluid overload
• People currently using, or who have used within the past 90 days, certain prescribed medications related to the excluded conditions listed above (some exceptions may apply — confirm with trial site)
• People who have had certain types of weight-loss surgery, including gastric bypass or bowel diversion surgery, or sleeve gastrectomy or lap band within the past year
• People who drink more than 14 standard alcoholic drinks per week (for males) or more than 7 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 positive drug screen for substances that are not lawfully prescribed (marijuana may be considered separately — confirm with trial site)
• People who work night shifts or have an unusual sleep-wake schedule within 30 days of screening, or expected to during the study
• People who have had a serious infection or fever-related illness within 14 days of screening
• People with any other health condition or test result that the study doctor believes could put them at risk or affect the study results
• People with a known allergy to any ingredient in the study medications (including sulfa drugs), IV equipment, plastics, adhesives, or silicone, or who have had reactions to IV medicines before
• People who are currently enrolled in another clinical drug trial or who have received an experimental treatment within a recent period (confirm with trial site for timing details)

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