GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis (RECAP-GLP1)
28 мая 2026 г. обновлено: DONG WU, Peking Union Medical College Hospital
Effects of GLP-1 Agonists on Prevention of HTG-Induced Acute Pancreatitis Recurrence: Protocol for a Randomized Clinical Trial
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.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Оцененный)
396
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Dong Wu, Medical Doctor
- Номер телефона: 8618612671010
- Электронная почта: dongwu@pumc.edu.cn
Места учебы
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Beijing Municipality
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Beijing, Beijing Municipality, Китай, 100730
- Peking Union Medical College Hospital
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Контакт:
- Dong Wu, Medical Doctor
- Номер телефона: 8618612671010
- Электронная почта: dongwu@pumc.edu.cn
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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.
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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.
Другие имена:
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Плацебо Компаратор: 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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Временное ограничение: Within 18 months after randomization
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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.
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Within 18 months after randomization
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Временное ограничение: 18 months after randomization
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Total number of recurrent HTG-AP episodes experienced by each participant during follow-up.
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18 months after randomization
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Change in fasting serum triglyceride level
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in fasting serum triglyceride concentration from baseline.
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in PAN-PROMISE score
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in patient-reported outcomes measured using the PAN-PROMISE questionnaire.
PAtieNt-rePoRted OutcoMe scale in acute pancreatItis, an international proSpEctive cohort study, (PAN-PROMISE scale) was designed and validated to evaluate the symptoms that cause the greatest discomfort and concern to patients with AP.
They include pain, abdominal distension, difficulty eating, difficulty with bowel movements, nausea or vomiting, thirst, and weakness.
Each symptom is scored (highest intensity in the last 24 hours) by the patient from 0 (none) to 10 (maximum possible intensity according to the patient's judgment), with a total score ranging from 0 to 70.
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in lipid profile parameters
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Changes in total cholesterol, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) from baseline.
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in glycemic parameters
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Changes in fasting serum glucose and hemoglobin A1C from baseline.
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in anthropometric measures
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Changes in body weight, body mass index (BMI), and waist circumference from baseline.
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in smoking
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Changes in self-reported smoking amount
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in alcohol consumption
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Changes in self-reported alcohol intake from baseline.
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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MRI assessment of hepatic and pancreatic fat infiltration and pancreatic volume
Временное ограничение: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Changes in MRI-based measurements of hepatic fat infiltration, pancreatic fat infiltration, and pancreatic volume from baseline.
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Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Incidence of metabolic and pancreatic complications
Временное ограничение: Within 18 months after randomization
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Incidence of stress hyperglycemia, post-acute pancreatitis diabetes mellitus, abdominal obesity, or pancreatic exocrine insufficiency.
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Within 18 months after randomization
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Incidence of chronic pancreatitis
Временное ограничение: 18 months after randomization
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Incidence of newly diagnosed chronic pancreatitis during follow-up.
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18 months after randomization
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Change in health-related quality of life
Временное ограничение: Baseline and 18 months after randomization
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Change in EQ-VAS score from baseline.
EQ VAS is a 0-100 scale where respondents are asked to indicate their overall health on the day they complete the questionnaire.
It is a visual analog scale.
The score ranges from 0 to 100 where 100 means the best health the patient can imagine, and 0 means the worst health the patient can imagine.
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Baseline and 18 months after randomization
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Pancreatitis-related unplanned readmission rate
Временное ограничение: 18 months after randomization
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Rate of unplanned hospital readmissions related to pancreatitis.
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18 months after randomization
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All-cause mortality
Временное ограничение: 18 months after randomization
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Death from any cause during study follow-up.
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18 months after randomization
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
1 сентября 2028 г.
Завершение исследования (Оцененный)
1 декабря 2028 г.
Даты регистрации исследования
Первый отправленный
14 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
28 мая 2026 г.
Первый опубликованный (Действительный)
1 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
1 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
28 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Хроническое заболевание
- Атрибуты болезни
- Метаболические заболевания
- Заболевания пищеварительной системы
- Заболевания поджелудочной железы
- Гиперлипидемии
- Дислипидемии
- Нарушения липидного обмена
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Панкреатит
- Панкреатит, хронический
- Гипертриглицеридемия
- Фармацевтические препараты
- Кристаллоидные решения
- Изотонические решения
- Решения
- Солевой раствор
- полуглутид
Другие идентификационные номера исследования
- 2026-RECAP-GLP1
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .