GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Trial sites (1)

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