Individualized Obesity Pharmacotherapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2022-05-26

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention group

Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise

Group Type EXPERIMENTAL

Phentermine-Topiramate

Intervention Type DRUG

Extended Release at dose of 7.5/46 mg oral daily

Liraglutide

Intervention Type DRUG

dose of 3 mg subcutaneous daily

Naltrexone/bupropion

Intervention Type DRUG

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)

Control Group

Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine

Group Type ACTIVE_COMPARATOR

Phentermine-Topiramate

Intervention Type DRUG

Extended Release at dose of 7.5/46 mg oral daily

Liraglutide

Intervention Type DRUG

dose of 3 mg subcutaneous daily

Naltrexone/bupropion

Intervention Type DRUG

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)

Phentermine

Intervention Type DRUG

15-37.5 mg oral daily

Interventions

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Phentermine-Topiramate

Extended Release at dose of 7.5/46 mg oral daily

Intervention Type DRUG

Liraglutide

dose of 3 mg subcutaneous daily

Intervention Type DRUG

Naltrexone/bupropion

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)

Intervention Type DRUG

Phentermine

15-37.5 mg oral daily

Intervention Type DRUG

Other Intervention Names

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Qsymia Saxenda Contrave Adipex-P Lomaira

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No