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:

• Children and teenagers between 4 years old and under 18 years old (male or female).
• People with very high triglyceride levels in their blood (500 mg/dL or above), a condition known as severe hypertriglyceridemia.
• People who have been diagnosed with a genetic condition called Familial Chylomicronemia Syndrome (FCS), either confirmed through genetic testing or diagnosed by a doctor based on clinical signs and ongoing high levels of fat particles in the blood called chylomicrons.
• People who have not been able to get their triglyceride levels under adequate control with previous treatments (for children under 8 years old, the trial doctor will decide whether this applies based on what treatments have been tried).
• Participants aged 6 and above must sign a consent form themselves; for anyone under 18, a parent or legal guardian must also sign the consent form (children under 6 are not required to sign themselves).
• Female participants who could potentially become pregnant must have a negative pregnancy blood test before joining.

Who may not be able to join:

• People who are currently taking part in another clinical trial, or who have recently taken an experimental drug without enough time having passed since the last dose (less than 30 days or 5 times the drug's natural clearance time in the body, whichever is longer).
• People who have used certain specific types of lipid-lowering drugs that target a protein called APOC3 — including ASO-based or siRNA-based medicines — within the 3 months before starting this trial.
• People who have had a sudden, severe inflammation of the pancreas (acute pancreatitis) within the month before starting the trial.
• People who have had major surgery within the 3 months before starting the trial and whom the trial doctor considers unsuitable due to the risk of serious side effects.
• People with certain abnormal liver test results (specifically, ALT or AST levels at or above twice the upper limit of the normal range).
• People with certain elevated levels of a substance called bilirubin in their blood (at or above 1.5 times the upper limit of normal).
• People whose kidneys are not functioning well enough, as measured by a specific kidney function calculation (eGFR below 30 mL/min/1.73 m²).
• People who show signs of protein in their urine above certain levels, which can indicate kidney problems.
• People with poorly controlled blood sugar levels, as measured by a blood test called HbA1c (a result of 9% or above).
• People with blood clotting problems that the trial doctor considers unsuitable for receiving the study drug.
• People who test positive for certain infections, including Hepatitis B, Hepatitis C (when both the antibody and RNA tests are positive), HIV, or syphilis.
• People with certain serious health conditions — such as major organ diseases, certain mental health disorders, hormonal conditions like Cushing's syndrome or hypothyroidism, a history of certain blood or lymph system disorders, or any cancer — where the trial doctor considers participation unsuitable due to risk of serious side effects.
• People taking other medicines or receiving treatments that the trial doctor believes could affect fat levels, liver or kidney function, blood clotting, or make it harder to assess whether the study drug is working.
• Female participants who are pregnant, breastfeeding, or planning to become pregnant.
• People with a known allergy or sensitivity to the study drug, any of its ingredients, or similar types of medicines.
• People with other health conditions that, in the trial doctor's opinion, could make it difficult to follow the study requirements or affect the reliability of the results.

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