Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy.

September 1, 2026 updated by: Fu Jen Catholic University Hospital

Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy: A Randomized Controlled Trial.

This study aims to evaluate the impact of a one-week discontinuation of long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RAs) prior to Esophagogastroduodenoscopy on gastric preparation quality and the need for repeat esophagogastroduodenoscopy (EGD), in order to determine whether a one-week drug interruption constitutes an appropriate pre-procedural recommendation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • New Taipei City, Taiwan, Taiwan, 24352

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Current use of GLP-1 receptor agonists (GLP-1 RAs) or tirzepatide (defined as discontinuation for no more than one week).

    • Continuous GLP-1 RA use for at least 4 weeks, or treatment at a near-maximal maintenance dose.
    • Scheduled to undergo esophagogastroduodenoscopy (EGD) for any indication.
    • Age between 18 and 70 years.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Provision of written informed consent.
    • Outpatient status.
    • If currently receiving medications that stimulate or inhibit gastrointestinal motility, these agents must be discontinued at least 3 days prior to EGD.

Exclusion Criteria:

  • • Severe comorbid conditions precluding safe EGD (e.g., unstable angina, recent myocardial infarction, heart failure, chronic respiratory disease, or bleeding diathesis).

    • History of prior upper gastrointestinal resection (stomach, intestine, or esophagus).
    • Any other condition deemed inappropriate by the treating physician.
    • Body mass index (BMI) > 40 kg/m².
    • Liver cirrhosis.
    • Parkinson's disease.
    • Dementia.
    • Use of tricyclic antidepressants or opioid medications for more than 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GLP-1 stop for 1 week
Drug: GLP-1 Stop for 1 week
Stop for 1 week
Placebo Comparator: GLP-1 not stop for 1 week
GLP-1 not stoping and under persistent use
Drug: GLP-1 non stop
GLP-1 non stop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
This scoring system is referred to as PEACE (Polprep: Effective Assessment of Cleanliness in Esophagogastroduodenoscopy)
Time Frame: "From enrollment to the end of treatment at least 30 days

After completion of all cleansing measures, cleanliness will be graded from 0 to 3 according to a predefined scoring system:

  • 0 = Completely obscured
  • 1 = Poor
  • 2 = Good

  • 3 = Excellent

    • This scoring system is referred to as PEACE (Polprep: Effective Assessment of Cleanliness in Esophagogastroduodenoscopy).

Assessments on the Day of Upper Gastrointestinal Endoscopy (Day 0)

Gastric preparation quality will be assessed using the PEACE system, and clinically significant lesions (CSLs) will be recorded as defined below:

  1. Esophagus

    • Esophageal polyps
    • Erosive reflux esophagitis
    • Endoscopic suspicion of Barrett's esophagus
    • Esophageal ulcer
    • Esophageal tumor
    • Esophageal subepithelial lesion

  2. Stomach

    • Gastric polyps
    • Gastric ulcer
    • Gastric tumor
    • Gastric subepithelial lesion

  3. Duodenum

    • Duodenal polyps
    • Duodenal ulcer
    • Duodenal tumor
    • Duodenal subepithelial lesion Polyps will be defined according to the Paris classification types 0-I and 0-II.
"From enrollment to the end of treatment at least 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Jen Catholic University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

July 26, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GLP-1 UGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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