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GLP-1 Agonists for Prevention of Recurrent Hypertriglyceridemic Acute Pancreatitis

NCT07617155 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2026-06-01

No results posted yet for this study

Summary

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.

Conditions

  • Hypertriglyceridemia Induced Acute Pancreatitis
  • Recurrent Acute Pancreatitis
  • Pancreatitis Relapsing
  • Hypertriglyceridemia

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617155 on ClinicalTrials.gov