GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis

Status

Not yet recruiting

Phase

Phase 4

Enrollment

396 participants (estimated)

Sponsor

Peking Union Medical College Hospital · Other

Design

Randomized · Quadruple masking

Countries

1 country

China

Start

Sept 2026 (estimated)

Primary completion

Sept 2028 (estimated)

Completion

Dec 2028 (estimated)

First posted

1 Jun 2026

Last update posted

1 Jun 2026

Conditions

Hypertriglyceridemia Induced Acute Pancreatitis · Recurrent Acute Pancreatitis · Pancreatitis Relapsing · Hypertriglyceridemia

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.

• Experimental

  Semaglutide

  Participants receive once-weekly subcutaneous semaglutide for 18 months. Semaglutide is initiated at 0.25 mg weekly for 4 weeks and escalated to 0.5 mg weekly thereafter. Participants also receive standard-of-care management and lifestyle modification counseling, including low-fat diet, physical activity, weight management, smoking cessation, and alcohol limitation.

• Placebo comparator

  Placebo

  Participants receive once-weekly matching placebo (normal saline) subcutaneous injections for 18 months following the same administration schedule as the experimental arm. Participants also receive standard-of-care management and lifestyle modification counseling, including low-fat diet, physical activity, weight management, smoking cessation, and alcohol limitation.

1. Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis

   Time frame · Within 18 months after randomization

   Registry description

   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.