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:

• People aged 18 to 55 years old (men and women)
• People with a body weight in a healthy range for their height, specifically a Body Mass Index (BMI) between 18.5 and 30
• People with blood pressure and heart rate within normal ranges when measured after sitting quietly for 5 minutes (systolic blood pressure 100–139, diastolic 50–89, heart rate 50–99 beats per minute)
• People whose kidneys are functioning well, based on a specific blood test result at the screening visit (confirm with trial site)
• People who have not smoked, used nicotine products, or used e-cigarettes for at least 3 months before the screening visit
• People who are able to fully understand the study, including its possible risks and side effects, and are willing and able to follow all study requirements
• Women who are unable to become pregnant, either due to natural menopause (no periods for at least 12 months) or because both ovaries have been surgically removed at least 6 weeks before joining; all women must have a negative pregnancy test at screening and at the start of each study part
• Men who are either sterile or who agree to use an approved form of contraception from the first dose until at least 90 days after the last dose — this applies even if their partner is currently pregnant (specific approved methods are listed and can be confirmed with the trial site)
• People who sign a written informed consent form before joining the study

Who may not be able to join:

• People with a clinically significant abnormal heart reading on a 12-lead ECG, particularly those with a QTcF interval greater than 450 milliseconds (confirm with trial site)
• People with significant abnormal physical findings that could interfere with the study
• People with abnormal blood test results at screening that suggest a physical illness, or a blood clotting measure (INR) above 1.2
• People with a significant medical history involving the kidneys, liver, digestive system, heart, lungs, skin, blood, hormones, or nervous system
• People who have had their gallbladder removed, have gallstones, or have other significant gallbladder problems
• People with a known or suspected allergy or sensitivity to the study drug or its ingredients, or a history of severe allergic reactions to any medication
• People who have taken any medications in the 3 weeks before the study starts, including over-the-counter medicines, vitamins, supplements, or herbal remedies
• People who have taken part in another clinical trial within 3 months before this study
• People who have donated blood within 3 months before this study
• People with a history of drug or alcohol misuse, or who regularly consume more than 1 alcoholic drink per day (women) or more than 2 per day (men), or more than 5 cups of coffee or tea per day
• People who test positive for COVID-19 on the day before the study begins
• People who test positive for cotinine (a marker of nicotine use) at screening
• People who test positive for drugs in a urine test at screening or the day before the study begins
• People who test positive for alcohol at screening or the day before the study begins
• People who follow an unusual diet (fewer than 1,600 or more than 3,500 calories per day), have made major changes to their eating habits in the 4 weeks before the study, or who follow a vegetarian or vegan diet
• Women who are pregnant, breastfeeding, capable of becoming pregnant, or who have a missing or positive pregnancy test at screening or the day before the study begins

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