Phase 3
Completed N=193
Individualized Obesity Pharmacotherapy
Source: ClinicalTrials.gov NCT03374956 ↗Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Change in Total Body Weight — -7.7; -6.5 percent change
◆ Published Evidence
Highly cited
192citations · ~38 / year
Selection of Antiobesity Medications Based on Phenotypes Enhances Weight Loss: A Pragmatic Trial in an Obesity Clinic.
Summary
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
Linked Publications
-
Selection of Antiobesity Medications Based on Phenotypes Enhances Weight Loss: A Pragmatic Trial in an Obesity Clinic.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Body Weight |
-7.7; -6.5 | — |
| SECONDARY Percentage of Responders |
44; 40 | — |
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) and the linked publication. 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. Informational only — not medical advice.