Status:
COMPLETED
A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 thi...
Eligibility Criteria
Inclusion
- Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
- Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
- Are agreeable to receiving study treatment by injections under the skin
Exclusion
- Have known allergies to tirzepatide or related compounds
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
- 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
- Have a prior history of malignant disease(s) in the past 5 years prior to screening
- Smoke more than the equivalent of 10 cigarettes per day
- Is a known user of drugs of abuse
Key Trial Info
Start Date :
September 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04050670
Start Date
September 13 2019
End Date
April 3 2020
Last Update
May 6 2023
Active Locations (1)
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1
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117