Status:
COMPLETED
A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide
Lead Sponsor:
Eli Lilly and Company
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04407234
Start Date
September 15 2020
End Date
January 7 2021
Last Update
January 8 2024
Active Locations (1)
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1
Clinical Pharmacology of Miami
Hialeah, Florida, United States, 33014