GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis

Официальное название

Effects of GLP-1 Agonists on Prevention of HTG-Induced Acute Pancreatitis Recurrence: Protocol for a Randomized Clinical Trial

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis [Срок оценки: Within 18 months after randomization]

Вторичные конечные точки (12)

• Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes [Срок оценки: 18 months after randomization]
• Change in fasting serum triglyceride level [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• Change in PAN-PROMISE score [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• Change in lipid profile parameters [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• Change in glycemic parameters [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• Change in anthropometric measures [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• Change in smoking [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• Change in alcohol consumption [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• MRI assessment of hepatic and pancreatic fat infiltration and pancreatic volume [Срок оценки: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months]
• Incidence of metabolic and pancreatic complications [Срок оценки: Within 18 months after randomization]
• Incidence of chronic pancreatitis [Срок оценки: 18 months after randomization]
• Change in health-related quality of life [Срок оценки: Baseline and 18 months after randomization]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Публикации

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Идентификаторы

NCT: NCT07617155 · 2026-RECAP-GLP1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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