Phase 2 Pancreatitis 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 years or older and under 80 years old at the time of signing the consent form, of any gender.
• People who understand what the trial involves and are willing to take part and sign a written consent form.

Who may not be able to join:

• People who have a history of gallstones, or currently have gallstones, unless their gallbladder was removed more than 3 months ago.
• People who had acute pancreatitis (sudden inflammation of the pancreas) that recovered 4 weeks or less before the screening visit.
• People who have had a cancer diagnosis in the past 5 years, with the exception of certain fully treated skin cancers or early-stage cervical cancer.
• People with severe heart failure (classified as Grade 3 or 4) at the time of screening.
• People who, in the 3 months before screening, had a heart attack, unstable chest pain, heart bypass surgery, a procedure to open blocked arteries, a stroke or mini-stroke, or were hospitalised for heart failure.
• People who have had serious heart rhythm problems in the 3 months before screening, such as frequent irregular heartbeats, fast abnormal heart rhythms, or a rapid heart rate due to atrial fibrillation.
• People who have had a serious infection in the 3 months before screening.
• People who have or have had kidney disease causing large protein loss (nephrotic syndrome), severe liver disease, Cushing's syndrome, or other conditions known to significantly affect fat levels in the blood.
• People who have or have had an overactive or underactive thyroid gland.
• People with poorly controlled high blood pressure (top number 180 mmHg or higher, and/or bottom number 110 mmHg or higher) at the time of screening.
• People with diabetes who were newly diagnosed within 12 weeks before screening, have a blood sugar control reading (HbA1c) of 8.0% or higher, or have Type 1 diabetes.
• People with unstable or severe problems affecting the liver, kidneys, heart, mental health, nervous system, hormones, blood, or other serious health conditions where the trial doctor considers participation unsafe.
• People who have had a serious injury or major surgery in the 6 months before screening, or who are planning major surgery during the trial.
• People who have had plasma exchange therapy (a blood-filtering treatment) within 4 weeks before screening, or who plan to have it during the trial.
• People who have used medications or supplements that significantly affect blood fat levels within 4 weeks before screening, including certain traditional medicines, other cholesterol-lowering drugs, niacin, red yeast rice, GLP-1 medications, or similar treatments, or who plan to use these during the trial.
• People who have used weight-loss medications or had weight-related surgery within 2 months before screening, or plan to do so during the trial.
• People with a history of drug misuse or heavy alcohol use (including drinking more than an average of 80 grams of pure alcohol per day, or having been diagnosed with alcohol-related disorders).
• People who made significant lifestyle changes in the 4 weeks before screening, or who are unwilling to follow lifestyle guidance or limit alcohol to less than 30 grams per day during the trial.
• People whose kidneys are not functioning well enough, based on a specific blood test formula (eGFR below 60 mL/min/1.73 m²).
• People with liver enzyme levels (ALT or AST) that are 3 or more times higher than the normal upper limit on blood tests.
• People with bilirubin levels (a measure of liver function) that are 2 or more times higher than the normal upper limit.
• People with a muscle enzyme level (creatine kinase) more than 1.5 times the normal upper limit.
• People with a low platelet count (below 100 x 10⁹/L) or a history of low platelets.
• People with very low haemoglobin levels (below 60 g/L), indicating severe anaemia.
• People who test positive for active syphilis, HIV, hepatitis C antibodies, or who have active hepatitis B infection above a certain level.
• People with thyroid-stimulating hormone (TSH) levels that are below the normal lower limit or more than 1.5 times the normal upper limit.
• People who took part in another drug clinical trial within 3 months before screening, or who are still within 5 half-lives of a previously tested drug, whichever period is longer.
• Women who are pregnant or breastfeeding.
• Women who could become pregnant and have not used contraception in the 30 days before screening, or people of any gender who are unwilling to follow the trial's contraception requirements or avoid donating eggs or sperm from the time of consent until the end of follow-up.
• People who the trial doctor considers unsuitable for any other reason.

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