A Study of Tirzepatide Concentrations at Different Injection Sites in Participants With Different Body Sizes
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Tirzepatide - Upper Arm Tirzepatide administered subcutaneously (SC) to the upper arm of healthy participants in one of three study periods. |
Drug: Tirzepatide
Tirzepatide administered SC
Other Names:
|
Experimental: Tirzepatide - Thigh Tirzepatide administered SC to the thigh of healthy participants in one of three study periods. |
Drug: Tirzepatide
Tirzepatide administered SC
Other Names:
|
Active Comparator: Tirzepatide - Abdomen Tirzepatide administered SC to the abdomen of healthy participants in one of three study periods. |
Drug: Tirzepatide
Tirzepatide administered SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [Predose through approximately Day 36 postdose]
PK: AUC of Tirzepatide
- PK: Maximum Concentration (Cmax) of Tirzepatide [Predose through approximately Day 36 postdose]
PK: Cmax of Tirzepatide
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
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Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
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Are agreeable to receiving study treatment by injections under the skin
Exclusion Criteria:
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Have known allergies to tirzepatide or related compounds
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Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
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Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
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Have a prior history of malignant disease(s) in the past 5 years prior to screening
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Smoke more than the equivalent of 10 cigarettes per day
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Is a known user of drugs of abuse
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Covance Clinical Research Inc | Daytona Beach | Florida | United States | 32117 |
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
Publications
None provided.- 17224
- I8F-MC-GPHI