Phase 3 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:

• You are male, or a female who is not pregnant, not breastfeeding, and not planning to become pregnant
• You have been diagnosed with severely high triglycerides (a type of fat in the blood) and have a documented record of fasting triglyceride levels at or above a very high threshold (880 mg/dL or higher)
• You have had at least one documented episode of pancreatitis (painful inflammation of the pancreas) in the last 60 months that was caused by high triglycerides, not another reason
• Your LDL ("bad") cholesterol level was at or below 130 mg/dL on your screening blood test
• Your blood sugar control measure (HbA1c, a 3-month average blood sugar test) was 9.5% or lower at screening
• You are willing to receive diet guidance and stick to a stable low-fat diet
• You are already taking standard medications to lower your cholesterol and triglycerides as recommended by your doctor (unless you have had a documented intolerance or those treatments have not worked for you)

Who may not be able to join:

• You have received certain gene-silencing injections (called siRNA) that target fats or triglycerides in the liver within the past year, unless it was a specific medication called inclisiran
• You have received certain other gene-silencing or similar targeted treatments within the past 60 days (or within a defined washout period, whichever is longer)
• You have had a pancreatitis episode within the 4 weeks before your start date in the trial
• Your body mass index (BMI, a measure of body weight relative to height) is above 45
• You are planning to have weight-loss surgery (such as bariatric surgery) at any point from signing consent through the end of the study
• You have a planned heart procedure (such as a stent or bypass surgery) scheduled during the study
• You have had an artery-clearing procedure within 16 weeks before your screening visit
• You have had a heart attack or similar acute heart event within 24 weeks before your screening visit
• You have had a recent cardiovascular event related to artery hardening/blockage within 24 weeks before your screening visit
• You have had a recent unstable or symptomatic irregular heartbeat (or related medication changes) within 90 days of screening (note: people with a stable, well-controlled heart rhythm condition may still be eligible — confirm with trial site)
• You have had a pacemaker or implanted heart device fitted within 30 days before your screening visit
• You have moderate-to-severe heart failure (New York Heart Association Class III or IV) or your heart's pumping function is below 30%
• You currently have nephrotic syndrome (a serious kidney condition causing protein loss in urine)
• You have advanced chronic kidney disease, defined by a kidney filtering rate (eGFR) below 20 mL/min/1.73 m²
• You have significant liver disease, including cirrhosis, advanced liver failure (Child-Pugh Class B or C), or liver enzyme levels more than 2.5 times the upper limit of normal at screening

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