Individualized Obesity Pharmacotherapy

Overview

The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.

Full Title of Study: “Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 26, 2022

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 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.

Interventions

  • Drug: Phentermine-Topiramate
    • Extended Release at dose of 7.5/46 mg oral daily
  • Drug: Liraglutide
    • dose of 3 mg subcutaneous daily
  • 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)
  • Drug: Phentermine
    • 15-37.5 mg oral daily

Arms, Groups and Cohorts

  • Experimental: Intervention group
    • Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
  • Active Comparator: Control Group
    • Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine

Clinical Trial Outcome Measures

Primary Measures

  • Change in Total Body Weight
    • Time Frame: baseline to 12 weeks
    • Percent change in body weight

Secondary Measures

  • Percentage of Responders
    • Time Frame: baseline to 12 weeks
    • Percentage of participants who loss 5% or more of total body weight
  • Percentage of Responders
    • Time Frame: baseline to 12 weeks
    • Percentage of participants with at least 10% total body weight loss

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andres J. Acosta, M.D., Ph.D., Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Andres J Acosta, Principal Investigator, Mayo Clinic

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