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Pause or pop? study tests if stopping GLP-1 drugs before endoscopy reduces stomach risks

NCT ID NCT06533527

Knowledge-focused Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 4 trial at the Cleveland Clinic enrolled 69 adults with type 2 diabetes or obesity who take GLP-1 medications. Participants were randomly assigned to either continue or pause their GLP-1 drug before an upper endoscopy. The goal was to see if holding the medication reduces the amount of food or liquid left in the stomach, which can interfere with the procedure or cause dangerous aspiration. The study did not test a new treatment but aimed to improve safety guidelines for common procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GLP-1 medications (e.g., tirzepatide, semaglutide, liraglutide, dulaglutide)
What this could lead to
If successful, this could lead to updated guidelines on whether to pause GLP-1 drugs before endoscopy to reduce stomach contents and aspiration risk.
What could go wrong
This is a small, single-center trial with only 69 participants. Results may not apply to all patients or settings, and the study does not test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

69 people

The number who actually took part.

Started

Jul 2024

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients using incretin-based therapies at a stable dose for more than 1 month. * Patients scheduled for outpatient esophagogastroduodenoscopy (EGD), endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP) under monitored anesthesia care. Exclusion Criteria: * Documented history of gastroparesis (based on a 4-hour solid-phase gastric emptying study) * Known history of achalasia * Surgical or genetically altered foregut anatomy * Known gastric outlet obstruction or pre-procedure imaging suggestive of gastric outlet obstruction. * Patients who did not follow the standard NPO (nil per oral) instructions.

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Conditions

The condition(s) this trial relates to.

gastroparesis Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Gastroparesis Obesity

Contacts and locations

Locations

  • Cleveland Clinic

    Weston, Florida, 33331, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

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