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GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis (RECAP-GLP1)

28 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

396

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Dong Wu, Medical Doctor
  • Numero di telefono: 8618612671010
  • Email: dongwu@pumc.edu.cn

Luoghi di studio

    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100730
        • Peking Union Medical College Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Altri nomi:
  • Ozempico
  • Wegovy
Comparatore 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Lasso di tempo: Within 18 months after randomization
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.
Within 18 months after randomization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Lasso di tempo: 18 months after randomization
Total number of recurrent HTG-AP episodes experienced by each participant during follow-up.
18 months after randomization
Change in fasting serum triglyceride level
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in fasting serum triglyceride concentration from baseline.
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in PAN-PROMISE score
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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.
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in lipid profile parameters
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
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
Change in glycemic parameters
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Changes in fasting serum glucose and hemoglobin A1C from baseline.
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in anthropometric measures
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Changes in body weight, body mass index (BMI), and waist circumference from baseline.
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in smoking
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Changes in self-reported smoking amount
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Change in alcohol consumption
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Changes in self-reported alcohol intake from baseline.
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
MRI assessment of hepatic and pancreatic fat infiltration and pancreatic volume
Lasso di tempo: Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Changes in MRI-based measurements of hepatic fat infiltration, pancreatic fat infiltration, and pancreatic volume from baseline.
Baseline, 1 month, 3 months, 6 months, 12 months, and 18 months
Incidence of metabolic and pancreatic complications
Lasso di tempo: Within 18 months after randomization
Incidence of stress hyperglycemia, post-acute pancreatitis diabetes mellitus, abdominal obesity, or pancreatic exocrine insufficiency.
Within 18 months after randomization
Incidence of chronic pancreatitis
Lasso di tempo: 18 months after randomization
Incidence of newly diagnosed chronic pancreatitis during follow-up.
18 months after randomization
Change in health-related quality of life
Lasso di tempo: Baseline and 18 months after randomization
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.
Baseline and 18 months after randomization
Pancreatitis-related unplanned readmission rate
Lasso di tempo: 18 months after randomization
Rate of unplanned hospital readmissions related to pancreatitis.
18 months after randomization
All-cause mortality
Lasso di tempo: 18 months after randomization
Death from any cause during study follow-up.
18 months after randomization

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

14 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

1 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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