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

28. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

396

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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-Komparator: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of participants with recurrent hypertriglyceridemia-induced acute pancreatitis
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking Union Medical College Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. September 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Mai 2026

Zuerst gepostet (Tatsächlich)

1. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-RECAP-GLP1

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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