A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide

• Status: Completed
• Trial end date: 2021-01-07
• Target enrollment: 0
• Participant gender: All

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 diabetes.

The study will last about 13 weeks for each participant, including screening.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Acetaminophen; Tirzepatide

Criteria

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