GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis (RECAP-GLP1)
28 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
396
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dong Wu, Medical Doctor
- Numéro de téléphone: 8618612671010
- E-mail: dongwu@pumc.edu.cn
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100730
- Peking Union Medical College Hospital
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Contact:
- Dong Wu, Medical Doctor
- Numéro de téléphone: 8618612671010
- E-mail: dongwu@pumc.edu.cn
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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Change in anthropometric measures
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 septembre 2028
Achèvement de l'étude (Estimé)
1 décembre 2028
Dates d'inscription aux études
Première soumission
14 mai 2026
Première soumission répondant aux critères de contrôle qualité
28 mai 2026
Première publication (Réel)
1 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies métaboliques
- Maladies du système digestif
- Maladies pancréatiques
- Hyperlipidémies
- Dyslipidémies
- Troubles du métabolisme lipidique
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Pancréatite
- Pancréatite chronique
- Hypertriglycéridémie
- Préparations pharmaceutiques
- Solutions cristalloïdes
- Solutions isotoniques
- Solutions
- Solution saline
- sémaglutide
Autres numéros d'identification d'étude
- 2026-RECAP-GLP1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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