Status:
COMPLETED
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. T...
Eligibility Criteria
Inclusion
- Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive
- Have a stable body weight in the past 1 month prior to screening
- Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Exclusion
- Have undergone gastric bypass or bariatric surgery
- Have a diagnosis of type 2 diabetes
- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
- Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
- Have any lifetime history of a suicide attempt
- Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening
- Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)
Key Trial Info
Start Date :
July 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04081337
Start Date
July 9 2020
End Date
May 26 2022
Last Update
February 8 2024
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808