A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide
Completed · Phase 1
Conditions studied: Overweight, Obesity, Diabetes Mellitus, Type 2
In brief
The purpose of this study is to learn more about how tirzepatide affects stomach emptying in overweight/very overweight participants. Participants include those without diabetes and those with type 2 diabetes. The study will last about 13 weeks for each participant, including screening.
Key facts
- Study ID
- NCT04407234
- Run by
- Eli Lilly and Company
- People needed
- 36
- Starts
- 2020-09-15
- Expected to finish
- 2021-01-07
- Last updated by the study team
- 2024-01-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening
- For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening
- For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months
- Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
- Key Exclusion Criteria
- Have undergone gastric bypass or bariatric surgery
- Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
- For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months
- Have any lifetime history of a suicide attempt
- Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
- Unwilling to comply with smoking and alcohol restrictions during the study
Where it is running
- Clinical Pharmacology of Miami — Hialeah, Florida, United States
Full record on ClinicalTrials.gov
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