How fasting length and pausing tirzepatide change stomach contents in people with type 2 diabetes or with overweight/obesity
A Study to Evaluate the Effect of Fasting Duration and Temporary Withholding of Tirzepatide on Retained Gastric Contents Using Gastric Ultrasound in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus
This test will see if longer fasting times and temporarily stopping tirzepatide change how much food and drink stays in the stomach after a meal for people with type 2 diabetes or with overweight/obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07299084 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study enrolls adults with type 2 diabetes or with overweight/obesity and uses ultrasound to measure stomach contents after a standardized test meal. Participants will undergo different fasting durations and will temporarily withhold tirzepatide as part of the protocol. Point-of-care ultrasound (POCUS) is used to quantify residual food and fluid in the stomach after the meal. The study aims to compare gastric content across fasting and withholding conditions to inform safe pre-procedure fasting recommendations.
Who should consider this trial
Good fit: Adults who have type 2 diabetes or are overweight/obese without type 2 diabetes, who meet other health criteria and can safely pause tirzepatide if required, are appropriate candidates.
Not a fit: People with conditions that affect gastric emptying, prior weight loss surgery, type 1 diabetes, or major medical problems are excluded and unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the results could help doctors recommend how long patients on tirzepatide should fast before procedures to reduce stomach contents and aspiration risk.
How similar studies have performed: Prior studies of GLP-1 receptor agonists have shown slowed gastric emptying, but tirzepatide's specific effects are less well established, so this work builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet one of the following criteria: * Have type 2 diabetes * Have obesity * Have overweight with at least one health issue related to weight but without type 2 diabetes Exclusion Criteria: * Have a condition that affects how their stomach empties * Have had weight loss surgery * Have type 1 diabetes * Have any major medical conditions or histories that could interfere with the study
Where this trial is running
Singapore
- Lilly Centre for Clinical Pharmacology — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 3176154559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.