Individualized Obesity Pharmacotherapy

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03374956

Collaborator

(none)

200

Enrollment

Location

Arms

66.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Phentermine-Topiramate Drug: Liraglutide Drug: Naltrexone/bupropion Drug: Phentermine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial

Actual Study Start Date :

Dec 11, 2017

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise	Drug: Phentermine-Topiramate Extended Release at dose of 7.5/46 mg oral daily Other Names: Qsymia Drug: Liraglutide dose of 3 mg subcutaneous daily Other Names: Saxenda 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) Other Names: Contrave
Active Comparator: Control Group Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine	Drug: Phentermine-Topiramate Extended Release at dose of 7.5/46 mg oral daily Other Names: Qsymia Drug: Liraglutide dose of 3 mg subcutaneous daily Other Names: Saxenda 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) Other Names: Contrave Drug: Phentermine 15-37.5 mg oral daily Other Names: Adipex-P Lomaira

Arm

Intervention/Treatment

Experimental: Intervention group

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

Drug: Phentermine-Topiramate

Extended Release at dose of 7.5/46 mg oral daily

Other Names:

Qsymia

Drug: Liraglutide

dose of 3 mg subcutaneous daily

Other Names:

Saxenda

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)

Other Names:

Contrave

Active Comparator: Control Group

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

Drug: Phentermine-Topiramate

Extended Release at dose of 7.5/46 mg oral daily

Other Names:

Qsymia

Drug: Liraglutide

dose of 3 mg subcutaneous daily

Other Names:

Saxenda

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)

Other Names:

Contrave

Drug: Phentermine

15-37.5 mg oral daily

Other Names:

Adipex-P

Lomaira

Outcome Measures

Primary Outcome Measures

Total Body Weight Loss [baseline, 12 weeks]
Change in body weight will be measured in kilograms

Secondary Outcome Measures

Percentage of responders [baseline,4 weeks, 12 weeks]
Percentage of participants who loss 5% or more of total body weight
Percentage of responders [baseline, 12 weeks, 6 months, 12 months]
Percentage of participants with at least 10% total body weight loss
Percentage of responders [baseline, 12 weeks]
Percentage of participants with 15% total body weight loss
Percentage of responders [baseline, 4 weeks, 12 weeks]
Percentage of participants who loss 5% or more of total body weight in each phenotype

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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