GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis (RECAP-GLP1)
2026年5月28日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
396
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Dong Wu, Medical Doctor
- 电话号码：8618612671010
- 邮箱：dongwu@pumc.edu.cn
学习地点
-
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100730
- Peking Union Medical College Hospital
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接触：
- Dong Wu, Medical Doctor
- 电话号码：8618612671010
- 邮箱：dongwu@pumc.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
其他名称：
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安慰剂比较：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
|
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in glycemic parameters
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年5月14日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 2026-RECAP-GLP1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.