GLP-1Phase 3NCT07736911
Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy.
A Phase 3 study testing GLP-1 Stop for 1 week and GLP-1 non stop in people with GLP-1, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- GLP-1
- What is being tested?
- GLP-1 Stop for 1 week and GLP-1 non stop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2026to Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
FJUH
New Taipei City, Taiwan, 24352
Kuan I Sung, 0928139643, danny520julia@gmail.com
About this study
Official title: 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.
- Conditions
- GLP-1
- Being tested
- GLP-1 Stop for 1 week, GLP-1 non stop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 Stop for 1 weekDrug
Stop for 1 week
GLP-1 non stopDrug
GLP-1 non stop
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 not stop for 1 week | Placebo comparator | GLP-1 not stoping and under persistent use Receives: Drug: GLP-1 non stop |
| GLP-1 stop for 1 week | Active comparator | GLP-1 stop for 1 week Receives: Drug: GLP-1 Stop for 1 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Esophagus
- Esophageal polyps
- Erosive reflux esophagitis
- Endoscopic suspicion of Barrett's esophagus
- Esophageal ulcer
- Esophageal tumor
- Esophageal subepithelial lesion
- Stomach
- Gastric polyps
- Gastric ulcer
- Gastric tumor
- Gastric subepithelial lesion
- 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.
Measured: "From enrollment to the end of treatment at least 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736911
- Sponsor's protocol ID
- GLP-1 UGI
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation One Week Recommendations for GLP-1 Receptor Agonists Prior to Esophagogastroduodenoscopy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07736911
- Acronym / sponsor ID
- GLP-1 UGI
- Conditions
- GLP-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 not stop for 1 week | Placebo comparator | Drug: GLP-1 non stopGLP-1 not stoping and under persistent use |
| GLP-1 stop for 1 week | Active comparator | Drug: GLP-1 Stop for 1 weekGLP-1 stop for 1 week |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Current use of GLP-1 receptor agonists (GLP-1 RAs) or tirzepatide (defined as discontinuation for no more than one week).
Key exclusion criteria (8 listed)
- • Severe comorbid conditions precluding safe EGD (e.g., unstable angina, recent myocardial infarction, heart failure, chronic respiratory disease, or bleeding diathesis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 Stop for 1 weekStop for 1 week | Drug | GLP-1 stop for 1 week |
| GLP-1 non stopGLP-1 non stop | Drug | GLP-1 not stop for 1 week |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GLP-1 Stop for 1 week and GLP-1 non stop in people with GLP-1, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuan I Sung (+886928139643, ioudanny520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.