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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
396
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dong Wu, Medical Doctor
- 電話番号：8618612671010
- メール：dongwu@pumc.edu.cn
研究場所
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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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コンタクト：
- Dong Wu, Medical Doctor
- 電話番号：8618612671010
- メール：dongwu@pumc.edu.cn
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年9月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年5月28日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月28日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-RECAP-GLP1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。