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

28 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

396

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Semaglutide
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.
Andere namen:
  • Ozempic
  • Wegovy
Placebo-vergelijker: 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.
Geneesmiddel: Placebo (Normal Saline)
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of recurrent hypertriglyceridemia-induced acute pancreatitis episodes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 18 months after randomization
Incidence of newly diagnosed chronic pancreatitis during follow-up.
18 months after randomization
Change in health-related quality of life
Tijdsspanne: 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
Tijdsspanne: 18 months after randomization
Rate of unplanned hospital readmissions related to pancreatitis.
18 months after randomization
All-cause mortality
Tijdsspanne: 18 months after randomization
Death from any cause during study follow-up.
18 months after randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Peking Union Medical College Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

14 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-RECAP-GLP1

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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