Obesity & Overweight
Conditions
Brief summary
A pragmatic, randomized, parallel-arm, controlled study of weight loss outcomes using AOMs guided by MyPhenome test.
Interventions
GENETICGenetic Test
The MyPhenome test is a genetic and clinical assessment that classifies individuals into biologically defined obesity phenotypes to guide personalized treatment. Using a saliva DNA sample combined with brief clinical inputs, the test predicts whether a patient has abnormalities in high CTSGRS ("Hungry Brain"), low CTSGRS ("Hungry Gut"), or hedonic eating ("Emotional Hunger").
Available AOMs will be: GLP-1 Receptor Agonists (semaglutide or tirzepatide), Phentermine-Topiramate ER, and naltrexone-bupropion SR
Sponsors
Phenomix Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults - age 18 or older * obesity (BMI ≥ 30 kg/m2) without obesity related diseases (ORDs). Or obesity (BMI ≥ 27 kg/m2) with obesity related diseases (ORDs). * Mayo Clinic employee or dependent * Referred to Community Internal Medicine Weight Management Program
Exclusion criteria
* Pregnancy or currently breast feeding. * No contraindications to the weight loss medications: Phentermine-Topiramate Extended Release (Qsymia®); Oral naltrexone extended-release/bupropion extended-release (NBSR; Contrave®, Mysimba™); Liraglutide (Saxenda®), Semaglutide (Wegovy®), and Tirzepatide (Zepbound®).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Weight Loss (TBWL) at 6 Months % | 6-Months | TWBL% at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TBWL% at 3 Months | 3-months | TBWL% at 3 Months |
| TBWL% at 9 Months | 9-Months | TBWL% at 9 Months |
| TBWL% at 12 Months | 12-Months | TBWL% at 12 Months |
| TBWL% at 18 Months | 18-Months | TBWL% at 18 Months |
| TBWL% at 24 Months | 24-Months | TBWL% at 24 Months |
| Degree of Treatment Response | 6-Months | 6-Months: non-responsive (\<3% TBWL), partial responsive (3%-15% TBWL), successful (\>15%-20% TBWL) and highly successful (\>20% TBWL) |
| Cost of Treatment | 3, 6, 9, 12, 18, 24 Months | Cost of Treatment |
| Cost-Effectiveness | 3, 6, 9, 12, 18, 24 Months | Cost-Effectiveness Pharmacy resource utilization data will be collected during the study. Pharmacotherapy costs will be directly compared between control and intervention groups and compared to weight loss outcomes. |
| Patient Satisfaction | 3, 6, 9, 12, 18, 24 Months | Client Satisfaction Questionnaire (CSQ-8): Given the design of the study, we will measure and evaluate patient satisfaction with a program of care rather than satisfaction with a specific medication. The satisfaction with the program will be evaluated with the adapted Client Satisfaction Questionnaire (CSQ-8). This is an 8-item measure that captures overall satisfaction with the care received, including perceived quality, whether care met patient needs, and willingness to recommend the program (each item score 1-4). The items will be lightly adapted to refer to weight management care with a total score ranging from 8 to 32 . |
Outcome results
None listed