Individualized Obesity Pharmacotherapy

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Phentermine-Topiramate; Drug: Liraglutide; Drug: Naltrexone/bupropion; Drug: Phentermine

• Registration Number: NCT03374956
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2017-11-09
• Study Start: 2017-12-11
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-15
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Results First Submitted: 2023-05-23
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-27
• Last Update Submitted: 2023-06-27
• Results First Posted: 2023-07-18
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Phentermine-Topiramate	Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Intervention group	Naltrexone/bupropion	Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Control Group	Phentermine-Topiramate	Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Control Group	Liraglutide	Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Control Group	Naltrexone/bupropion	Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Control Group	Phentermine	Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Intervention group	Liraglutide	Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise

Primary Outcome Measures

Name	Time	Method
Change in Total Body Weight	baseline to 12 weeks	Percent change in body weight

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders	baseline to 12 weeks	Percentage of participants with at least 10% total body weight loss

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States