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

NCT07736911 | Recruiting Phase 3 DMC

• 1 other identifier: GLP-1 UGI
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GLP-1

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

GLP-1 not stop for 1 week

PLACEBO COMPARATOR

GLP-1 stop for 1 week

Drug: GLP-1 non stop

GLP-1 stop for 1 week

ACTIVE COMPARATOR

GLP-1 stop for 1 week

Drug: Stop for 1 week

Interventions

Stop for 1 week DRUG

Stop for 1 week

GLP-1 stop for 1 week

GLP-1 non stop DRUG

GLP-1 non stop

GLP-1 not stop for 1 week

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (1)

FJUH

New Taipei City, Taiwan, 24352, Taiwan

RECRUITING

Central Study Contacts

Kuan I Sung

CONTACT

+886928139643; ioudanny520@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: July 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)