Semaglutide: Semaglutide is administered as a once-weekly subcutaneous injection for 18 months. Treatment is initiated at 0.25 mg once weekly for the first 4 weeks and escalated to 0.5 mg once weekly thereafter to improve tolerability.
Placebo (Normal Saline): Placebo consists of normal saline administered as a once-weekly subcutaneous injection following the same administration schedule as semaglutide for 18 months. Participants receive 0.25 mg-equivalent injection volume once weekly for the first 4 weeks followed by 0.5 mg-equivalent injection volume once weekly thereafter.
Study summary
Hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is associated with a high risk of recurrence despite standard lipid-lowering therapy and lifestyle modification. The goal of this clinical trial is to evaluate whether GLP-1 receptor agonist therapy can reduce the recurrence of HTG-AP in adults with a history of HTG-AP and hypertriglyceridemia.
The main questions this study aims to answer are:
* Whether GLP-1 receptor agonist therapy reduces the recurrence rate of HTG-AP.
* Whether GLP-1 receptor agonist therapy improves triglyceride control, body weight, and metabolic parameters.
* Whether GLP-1 receptor agonist therapy is safe and well tolerated in this patient population.
Researchers will compare GLP-1 receptor agonist therapy plus standard care with standard care alone to determine whether GLP-1 receptor agonist therapy provides additional benefit in preventing recurrent HTG-AP.
Participants will:
* Receive either GLP-1 receptor agonist therapy plus standard care or standard care alone.
* Undergo regular clinical follow-up visits and laboratory assessments.
* Receive monitoring of triglyceride levels, recurrence events, metabolic outcomes, and adverse events during the study period.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
* Age ≥ 18 years old
* Previous diagnosis of index HTG-AP (defined as AP with serum TG \>1000 mg/dL or a serum TG level of 500-1000 mg/dL accompanied by chylous serum)36-38
* Having HTG as the exclusive cause of AP
* Time from discharge of index HTG-AP to recruitment between 4 weeks to 3 months, without AP-related symptoms between discharge and recruitment
* Expression of the willingness to comply with lifestyle modification during the study period.
* Clinically stable at the time of inclusion
* The ability to understand the trial and completing it, as evaluated by the investigators.
* Patients who may get pregnant should ensure using contraceptives for 20 months after inclusion Exclusion Criteria
* History of malignancy in past 5 years
* History of hypothyroidism, nephrotic syndrome, Cushing's syndrome or AIDS
* History of chronic pancreatitis or pancreatic neoplasm
* History of severe cardiovascular and pulmonary diseases, such as heart failure, coronary heart disease and chronic obstructive pulmonary disease.
* Severe renal deficiency (glomerular filtration rate \< 30 ml/min)
* Severe hepatic deficiency (Child-Pugh Class B or C)
* Previous pancreatic surgery
* Recurrent AP due to pancreatic diverticulum
* Recurrent AP due to known genetic mutations (eg. CFTR)
* Personal or family history of medullary thyroid carcinoma (MTC)
* Current or prior diagnosis or suspected diagnosis of multiple endocrine neoplasia type 2 (MEN2)
* Serious hypersensitivity reaction to semaglutide or any of the excipients in the investigational drug or placebo
* Pregnancy
* Breast-feeding
Primary outcome measure(s)
Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis — Within 18 months after randomization Recurrent hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is defined as an episode of acute pancreatitis occurring at least 1 month after complete symptom resolution from the index episode, with serum triglycerides \>1000 mg/dL or triglycerides 500-1000 mg/dL accompanied by chylous serum and no other identifiable cause of acute pancreatitis.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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