Obesity
Conditions
Keywords
Pharmacological, Obesity Management, Individualized
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.
Interventions
Extended Release at dose of 7.5/46 mg oral daily
DRUGLiraglutide
dose of 3 mg subcutaneous daily
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)
DRUGPhentermine
15-37.5 mg oral daily
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Body Weight | baseline to 12 weeks | Percent change in body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders | baseline to 12 weeks | Percentage of participants who loss 5% or more of total body weight |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
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) | 93 |
| Control Group Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
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)
Phentermine: 15-37.5 mg oral daily | 100 |
| Total | 193 |
Baseline characteristics
| Characteristic | Control Group | Total | Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 193 Participants | 93 Participants |
| Age, Continuous | 39 years STANDARD_DEVIATION 14 | 39 years STANDARD_DEVIATION 15 | 38.5 years STANDARD_DEVIATION 16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) White | 87 Participants | 175 Participants | 88 Participants |
| Region of Enrollment United States | 100 Participants | 193 Participants | 93 Participants |
| Sex: Female, Male Female | 78 Participants | 143 Participants | 65 Participants |
| Sex: Female, Male Male | 22 Participants | 50 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 100 |
| other Total, other adverse events | 23 / 93 | 25 / 100 |
| serious Total, serious adverse events | 0 / 93 | 0 / 100 |
Outcome results
Primary
Change in Total Body Weight
Percent change in body weight
Time frame: baseline to 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Change in Total Body Weight | -7.7 percent change |
| Control Group | Change in Total Body Weight | -6.5 percent change |
Secondary
Percentage of Responders
Percentage of participants who loss 5% or more of total body weight
Time frame: baseline to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Percentage of Responders | 81 percentage of participants |
| Control Group | Percentage of Responders | 80 percentage of participants |
Secondary
Percentage of Responders
Percentage of participants with at least 10% total body weight loss
Time frame: baseline to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Percentage of Responders | 44 percentage of participants |
| Control Group | Percentage of Responders | 40 percentage of participants |