Individualized Obesity Pharmacotherapy

Study Overview
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Brief Summary
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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
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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 lifestyle intervention.All participants will be seen at 4 and 12 weeks. At the 12-week visit, participants will be unblinded to their obesity-related phenotype and they could contact their physician to continue a FDA-approved medication as part of clinical care. Study team will prospectively follow the patients' weight, waist circumference and use of obesity medications every 3 months for 1 year.

Official Title
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Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial

Conditions
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Obesity

Intervention / Treatment
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* Drug: Phentermine-Topiramate
* Drug: Liraglutide
* Drug: Naltrexone/bupropion
* Drug: Phentermine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise | Drug: Phentermine-Topiramate<br>* Extended Release at dose of 7.5/46 mg oral daily<br>* Other names: Qsymia;Drug: Liraglutide<br>* dose of 3 mg subcutaneous daily<br>* Other names: Saxenda;Drug: Naltrexone/bupropion<br>* Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)<br>* Other names: Contrave;|
| Active Comparator: Control Group<br>Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine | Drug: Phentermine-Topiramate<br>* Extended Release at dose of 7.5/46 mg oral daily<br>* Other names: Qsymia;Drug: Liraglutide<br>* dose of 3 mg subcutaneous daily<br>* Other names: Saxenda;Drug: Naltrexone/bupropion<br>* Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)<br>* Other names: Contrave;Drug: Phentermine<br>* 15-37.5 mg oral daily<br>* Other names: Lomaira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Body Weight | Percent change in body weight | baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders | Percentage of participants who loss 5% or more of total body weight | baseline to 12 weeks | 
| Percentage of Responders | Percentage of participants with at least 10% total body weight loss | baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacological, Obesity Management, Individualized