Status:
COMPLETED
Individualized Obesity Pharmacotherapy
Lead Sponsor:
Mayo Clinic
Conditions:
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
Detailed Description
All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity. All participants will receive a standard intense lifes...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adults with obesity (BMI \>30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.
- Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.
- Exclusion criteria
- Abdominal bariatric surgery
- Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months.
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
- Hypersensitivity to any of the study medications.
- No contraindications to all FDA-approved medications
Exclusion
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2022
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT03374956
Start Date
December 11 2017
End Date
May 26 2022
Last Update
July 18 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905