GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis (RECAP-GLP1)
28 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
396
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Dong Wu, Medical Doctor
- Número de teléfono: 8618612671010
- Correo electrónico: dongwu@pumc.edu.cn
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100730
- Peking Union Medical College Hospital
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Contacto:
- Dong Wu, Medical Doctor
- Número de teléfono: 8618612671010
- Correo electrónico: dongwu@pumc.edu.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2028
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades metabólicas
- Enfermedades del Sistema Digestivo
- Enfermedades pancreáticas
- Hiperlipidemias
- Dislipidemias
- Trastornos del metabolismo de los lípidos
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Pancreatitis
- Pancreatitis Crónica
- Hipertrigliceridemia
- Preparaciones farmacéuticas
- Soluciones cristaloides
- Soluciones isotónicas
- Soluciones
- Solución salina
- semaglutida
Otros números de identificación del estudio
- 2026-RECAP-GLP1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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