Phase 3
N=193
Individualized Obesity Pharmacotherapy
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03374956 ↗Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Total Body Weight — -7.7; -6.5 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Phentermine-Topiramate (Drug); Liraglutide (Drug); Naltrexone/bupropion (Drug); Phentermine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Body Weight |
-7.7; -6.5 | — |
| SECONDARY Percentage of Responders |
44; 40 | — |
| SECONDARY Percentage of Responders |
44; 40 | — |
Summary
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03374956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.