A Study to Measure Stomach Emptying in Overweight Non-diabetic and Diabetic Participants Using Tirzepatide
Study Details
Study Description
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 diabetes.
The study will last about 13 weeks for each participant, including screening.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Tirzepatide + Acetaminophen Tirzepatide administered subcutaneously (SC) and acetaminophen administered orally. |
Drug: Tirzepatide
Tirzepatide administered SC.
Other Names:
Drug: Acetaminophen
Acetaminophen administered orally.
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (PK): Time of Maximum Concentration (Tmax) of Acetaminophen [Pre-dose through 36 hours post-dose on Day-1]
PK: Tmax of Acetaminophen
- PK: Tmax of Acetaminophen [Pre-dose through 36 hours post-dose on Day 2]
PK: Tmax of Acetaminophen
- PK: Tmax of Acetaminophen [Pre-dose through 36 hours post-dose on Day 37]
PK: Tmax of Acetaminophen
Secondary Outcome Measures
- Change from Baseline in Hemoglobin A1c (HbA1c) [Pre-dose through 9 weeks]
Change from Baseline in HbA1c
- PK: AUC(0-tlast) of Tirzepatide at Steady State [Pre-dose through 9 weeks]
PK: AUC(0-tlast) of Tirzepatide at Steady State
- PK: Cmax of Tirzepatide at Steady State [Pre-dose through 9 weeks]
PK: Cmax of Tirzepatide at Steady State
Eligibility Criteria
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
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Have undergone gastric bypass or bariatric surgery
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Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
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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
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Have any lifetime history of a suicide attempt
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clinical Pharmacology of Miami | Hialeah | Florida | United States | 33014 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17376
- I8F-MC-GPHU