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:

For all parts of the trial:

• People who are able and willing to attend all required study visits at the trial site.
• People who are willing to give written consent to participate after the study has been fully explained to them.
• People whose kidneys are working at a normal level (confirmed by a blood test measuring kidney filtration rate).
• Women who are not pregnant and not breastfeeding, and who agree to use highly effective contraception from the screening visit until at least 90 days after their last dose of the study drug (this does not apply to women who only have same-sex partners or who are fully abstinent as their usual lifestyle).
• Women who are past menopause (confirmed by at least 12 months without a period, and a hormone blood test if needed), or who have a negative pregnancy test at the screening visit.
• Women who agree not to donate eggs for at least 90 days after their last dose of the study drug.
• Men who have had a vasectomy (with documented proof), or who agree to use a condom and an additional contraceptive method if their partner could become pregnant, from the day before first dosing until the end of the study (this does not apply to men who only have same-sex partners or who are fully abstinent as their usual lifestyle).
• Men who agree not to donate sperm for at least 90 days after their last dose of the study drug.
• People who are willing to avoid tobacco and other nicotine products while at the study site and during the treatment period.

For Parts A and B only (healthy volunteer sections):

• People aged 18 to 55 years old at the time of giving consent.
• People in generally good health with no significant medical history and no concerning findings on a physical examination.
• People whose routine blood test results fall within the normal range (or are considered not significant by the doctor).
• People with a body mass index (BMI) between 18.0 and 30.0, and who weigh no more than 120 kg.

For Part C only (the NASH patient section):

• People aged 18 to 65 years old at the time of giving consent.
• People who have been diagnosed with a liver condition called NASH (non-alcoholic steatohepatitis), confirmed by one or more of: a liver biopsy, a clinical diagnosis alongside signs of metabolic conditions (such as obesity, high blood pressure, or diabetes), or specific liver scan scores (confirm with trial site).
• People whose liver enzyme levels (ALT) have been above the normal upper limit on at least two separate occasions in the past 6 months, with at least one result from the screening visit and the two readings at least 2 weeks apart.
• People whose liver scan results (FibroScan) fall within specific ranges that suggest moderate liver fat and stiffness, but not severe scarring (confirm with trial site for exact values).
• People who have not lost more than 5% of their body weight in the 6 months before screening.
• People who are taking certain medications (GLP-1 agonists, SGLT2 inhibitors, or vitamin E above 400 IU/day) and have been on a stable dose for at least 3 months.
• People with a platelet count above 150,000 and a blood protein (albumin) level of at least 35 g/L.
• People with a BMI between 18.0 and 40.0.

Who may not be able to join:

For all parts of the trial:

• People with a physical or mental health condition that, in the doctor's opinion, would make it difficult to complete the study as required.
• People who have donated blood or lost more than 500 mL of blood in the 60 days before the first dose.
• People who have donated plasma in the 7 days before the first dose.
• People who have had a fever above 37.7°C or a viral or bacterial infection with symptoms in the 2 weeks before the first dose.
• People who have difficulty swallowing and would not be able to swallow the study capsules.
• People with a history of severe allergic reactions, including anaphylaxis, or known sensitivity to the study drug or any of its ingredients (the capsule contains several listed components — confirm with trial site).
• People with clinically significant abnormal findings on physical examination.
• People with a heart rhythm abnormality on an ECG, including a QT interval measurement that is above the accepted threshold (confirm with trial site).
• People with unstable or out-of-range blood pressure, or a heart rate that is too low (below 45 beats per minute) or too high (above 100 beats per minute) at screening.
• People with a history or current diagnosis of liver disease caused by other factors such as genetics, autoimmune conditions, viruses, or alcohol.
• People with cirrhosis of the liver, as shown by a history of serious liver complications, a previous biopsy result showing advanced scarring (F4), or imaging evidence of cirrhosis.
• People who have had a major hospitalisation or major surgery in the 6 months before screening.
• People who needed antibiotics given through a drip (intravenously) for an infection in the 6 months before screening.
• People who have received a live vaccine in the 4 weeks before the first dose.
• People who have taken a strong immune-suppressing drug (including experimental drugs from other trials) within 4 months before screening, or within 5 half-lives of that drug, whichever is longer.
• People who test positive for HIV, hepatitis B, or hepatitis C at screening.
• People with a history of substance abuse or recreational intravenous drug use in the past 12 months (by self-report).
• People who have participated in another clinical trial involving an experimental drug or device within the required washout period (30 days for small-molecule drugs, 90 days for biological drugs, or longer depending on the drug's half-life).
• People with cardiovascular conditions including certain types of heart failure, atrial fibrillation requiring blood thinners, or other heart conditions considered significant by the investigating doctor.
• People who have had bariatric (weight-loss) surgery.
• People where the investigating doctor has any other concern about their safety, ability to complete the study, or the reliability of the study results.

For Parts A and B only:

• People taking prescription medications (other than hormonal contraception), supplements, herbal remedies, vitamins, or over-the-counter medicines within 48 hours of dosing and throughout the study, unless approved by the doctor (simple pain relief such as paracetamol under 2 g/day may be allowed at the doctor's discretion).
• People with a clinically significant history of major conditions affecting the gut, heart, muscles, joints, hormones, blood, mental health, kidneys, liver, lungs, nerves, immune system, or fat metabolism, or a history of drug hypersensitivity.
• People with a current or past diagnosis of cancer (though people with certain successfully treated skin cancers may be considered at the doctor's discretion).
• People who test positive for recreational drugs (including methamphetamine, opiates, cocaine, cannabis, and others) or for alcohol at screening or before dosing.
• People with a history of alcohol use disorder in the past 9 months, or who regularly drink more than 10 standard drinks per week or more than 4 standard drinks on any single day, or who cannot avoid alcohol for at least 72 hours before screening and before dosing, and throughout the study.

For Part C only:

• People whose liver enzyme levels (ALT) are 5 times or more above the normal upper limit, or whose AST enzyme level is higher than their ALT in a specific pattern (confirm with trial site).
• People taking certain medications that interact with liver enzymes (including specific blood thinners, anti-seizure drugs, and others listed) — confirm with trial site for the full list of affected medications.
• People with uncontrolled medical conditions (confirm with trial site).
• People with a significant recent history of heart disease, heart attack, stroke, or related events in the 6 months before the first dose.
• People with poorly controlled diabetes (HbA1c blood sugar level above 9.0% at screening).
• People with a cancer diagnosis in the past 5 years (though people with certain successfully treated skin cancers may be considered at the doctor's discretion).
• People with a history or current condition associated with significant suppression of the immune system.
• People who test positive for recreational drugs at screening or before dosing (a positive result explained by a prescribed medication may be allowable).
• People with a history of alcohol use disorder in the past 9 months, or who regularly drink more than 10 standard drinks per week or more than 4 standard drinks in a single day, or who cannot limit alcohol to these levels during the study, or who cannot avoid alcohol for 72 hours before screening and before dosing.

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