Trial on holding GLP-1 or GIP drugs before endoscopy stops early over stomach contents

The first randomized trial testing whether patients should pause a GLP-1 or GIP agonist before upper endoscopy stopped enrolling early after far more patients who kept taking their drug had significant amounts of stomach contents remaining, according to results published in JAMA Internal Medicine ^[1].

The OCULUS trial assigned patients taking a GLP-1 or GIP agonist to either hold one dose before the procedure or continue the drug as usual ^[1]. At a planned interim analysis of 60 patients, clinically significant residual gastric volume was found in 3.1 percent of the group that held a dose, compared with 25.0 percent of the group that continued ^[1]. That gap was the reason the trial was halted ^[1].

Neither group recorded an aspiration event, and no patient in either arm needed intubation ^[1].

The trial also turned up a signal about food, not just medication. Among the 25 patients who consumed only clear liquids the day before their procedure, none had clinically significant residual volume, regardless of whether they had held their dose ^[1]. That subgroup was small, and the finding points to the pre-procedure diet as a factor alongside the drug hold ^[1].

The study was led by researchers at Cleveland Clinic Florida and included investigators from Cleveland Clinic in Ohio, the University of Missouri in Columbia and the MetroHealth Medical System in Cleveland ^[1]. Two corrections have since been published for the article, one for its visual abstract and one for Figure 2 ^[1].

It has not been reported whether the results differed by individual drug, dose or how long a patient had been on treatment. The full target enrollment for the trial has not been disclosed, and it is not yet known whether the trial will resume or report longer follow-up.

Why it matters for patients

People who take semaglutide (Ozempic, Wegovy, Rybelsus) or tirzepatide (Mounjaro, Zepbound) are often told to stop the drug for a period before surgery or a procedure, a practice that until now rested mainly on reports of food left in the stomach rather than on a randomized comparison ^[1]. This trial is the first to assign patients at random to hold or continue, which makes its numbers more directly useful to the clinicians who write those instructions.

The practical takeaway from the 60-patient analysis cuts two ways. Holding one dose lowered the rate of significant residual stomach contents from about one in four to about one in thirty, but it did not drive the rate to zero ^[1]. In the small group that stuck to clear liquids the day before, the rate was zero whether or not the drug was held ^[1]. Because only 25 patients fell into that clear-liquid group, the finding is a signal worth studying rather than a settled rule.

Guidance for patients on GLP-1 and GIP drugs before endoscopy has varied between professional societies and institutions, and this trial does not by itself settle what any individual's care team should recommend. Patients facing an upper endoscopy who take one of these drugs can expect questions about their dose schedule and their diet in the days before the procedure, and can raise the trial's findings with the gastroenterologist or anesthesiologist managing their case.

What happens next

The trial stopped at its interim analysis rather than at its planned end, so the results rest on a small number of patients ^[1]. No timeline for a longer report, a resumption of enrollment or updated professional guidance has been announced ^[1]. The published article carries two corrections, one to the visual abstract and one to Figure 2, which readers checking the study should account for ^[1].