CompletedPhase 4Results posted

Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Randomized Trial of Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Lead sponsor

The Cleveland Clinic

Assets

Dulaglutide / Liraglutide / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Actual enrollment

Study population

Perioperative / gastric aspiration risk

Eligibility highlights

Primary endpoints

•Presence of RGV in Stomach•Tracking the Use of Intubation Due to RGV•Aspiration Events Due to RGV

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06533527

Org study ID24-301

Timeline

Milestones

Study start2024-07-31actual

Study first posted2024-08-01actual

Primary completion2025-05-20actual

Study completion2025-05-20actual

Last update posted2025-12-05actual

Results first posted2025-12-05actual

Assets

Investigational agents

Dulaglutide Liraglutide Semaglutide Tirzepatide

Who this study enrolls

Perioperative / gastric aspiration risk

Who can enroll

SexAll

Healthy volunteersAccepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

5 endpoints

Primary/registry result

Tracking the Use of Intubation Due to RGV

Time frame:Procedure

event count, event

Posted result

Group	Participants	95% CI
Continue medication as normal prior to endoscopic procedure	0	-
Hold dose prior to endoscopic procedure	0	-

Primary/registry result

Aspiration Events Due to RGV (Residual Gastric Volume)

Time frame:Procedure

event count, event

Posted result

Group	Number · number of aspiration events	95% CI
Continue medication as normal prior to endoscopic procedure	0	-
Hold dose prior to endoscopic procedure	0	-

Primary/protocol endpoint

Presence of RGV (Residual Gastric Volume) in Stomach

Time frame:Procedure

categorical status, event

Primary/protocol endpoint/low confidence

Tracking the Use of Intubation Due to RGV

Time frame:Procedure

event count, event

Primary/protocol endpoint

Aspiration Events Due to RGV (Residual Gastric Volume)

Time frame:Procedure

event count, event

Other clinical outcomes

1 endpoint

Primary/registry result

Presence of RGV (Residual Gastric Volume) in Stomach

Time frame:Procedure

categorical status, event

Posted result

Group	Participants	95% CI
Continue medication as normal prior to endoscopic procedure	7	-
Hold dose prior to endoscopic procedure	1	-

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Holding vs Continuing GLP-1/GIP Agonists Before Upper Endoscopy: The OCULUS Randomized Clinical Trial.
JAMA internal medicine2026 May 1PMID41837981doi:10.1001/jamainternmed.2026.0027via clinicaltrials gov reference derived + pubmed nct search
Relationship between perioperative semaglutide use and residual gastric content: A retrospective analysis of patients undergoing elective upper endoscopy.
Journal of clinical anesthesia2023 Aug (month)PMID36870274doi:10.1016/j.jclinane.2023.111091via CT.gov reference
Association of glucagon-like peptide-1 receptor agonist treatment with gastric residue in an esophagogastroduodenoscopy.
Journal of diabetes investigation2023 Jun (month)PMID36919944doi:10.1111/jdi.14005via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.