Early Phase 1 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 between 18 and 55 years old (inclusive) at the time of signing the consent form.
• You are on standard treatment for high triglycerides but your fasting triglyceride levels have not consistently dropped below 10 mmol/L (880 mg/dL) — shown by at least three separate blood test results above this level before screening — or you cannot tolerate standard treatment.
• You score 45 or higher on a specific questionnaire used to assess a condition called Familial Chylomicronemia Syndrome (a genetic disorder causing very high triglycerides) (confirm with trial site).
• You are able to sign the consent form and follow the study's requirements, including dietary guidelines.
• If you are a woman who could become pregnant, you have a negative pregnancy test at the start of the study and agree to use reliable contraception throughout; if you cannot become pregnant (for example, due to surgery or being post-menopausal for at least one year), you meet those conditions instead.
• If you are a man who could father a child, you agree to use reliable contraception for the full observation period after your dose; if you cannot (for example, after a vasectomy), you can provide medical records confirming this.

Who may not be able to join:

• You are currently in another clinical trial, or you recently used an experimental treatment and have not waited long enough since your last dose (at least 30 days or 5 times the drug's half-life, whichever is longer).
• You have used certain specific lipid-lowering medicines that target a protein called APOC3 (such as certain ASO or siRNA therapies) within the past 6 months (confirm with trial site).
• You have had acute pancreatitis (sudden, severe inflammation of the pancreas) within the past 3 months.
• You have had a serious heart event such as a heart attack or unstable chest pain within the past 6 months, or you have previously had heart bypass surgery, angioplasty, or a stent placed in your heart arteries.
• You have had major surgery within the past 3 months that, in the doctor's opinion, would make it unsafe for you to join this study.
• Your recent blood tests show certain abnormal results, including: liver enzyme levels (ALT or AST) that are too high; elevated bilirubin levels; reduced kidney function; too much protein in your urine; LDL cholesterol above 130 mg/dL; or blood sugar control (HbA1c) of 9% or above.
• Your blood clotting test results are abnormal in a way the investigator feels would make the study drug unsafe for you (confirm with trial site).
• You tested positive at screening for hepatitis B, hepatitis C, HIV, or syphilis.
• You have a known serious disease affecting a major organ, a psychiatric condition, a hormonal disorder called Cushing's syndrome, or cancer that the investigator feels would make participation unsafe for you.
• You are taking other medicines or receiving treatments that the investigator believes could affect your fat levels, liver, kidneys, or blood clotting, or could interfere with the study results — including certain steroids, anabolic steroids, some HIV medicines (used within the last 4 weeks), plasma exchange, recent blood donation, or significant blood loss.
• You are planning to become pregnant, are currently pregnant, or are breastfeeding.

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