Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Phentermine-Topiramate
- Conditions
- Obesity
- Sponsor
- Mayo Clinic
- Enrollment
- 193
- Locations
- 1
- Primary Endpoint
- Change in Total Body Weight
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Intervention: Phentermine-Topiramate
Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Intervention: Liraglutide
Intervention group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Intervention: Naltrexone/bupropion
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Intervention: Phentermine-Topiramate
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Intervention: Liraglutide
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Intervention: Naltrexone/bupropion
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Intervention: Phentermine
Outcomes
Primary Outcomes
Change in Total Body Weight
Time Frame: baseline to 12 weeks
Percent change in body weight
Secondary Outcomes
- Percentage of Responders(baseline to 12 weeks)