Not yet recruiting NCT07728812
Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Genetic Test, Anti-Obesity Medication (AOM) treatment.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy (PhenoRX Pragmatic Trial)
Overview
A pragmatic, randomized, parallel-arm, controlled study of weight loss outcomes using AOMs guided by MyPhenome test.
Interventions
- Genetic Genetic 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"). - Drug Anti-Obesity Medication (AOM) treatment
Available AOMs will be: GLP-1 Receptor Agonists (semaglutide or tirzepatide), Phentermine-Topiramate ER, and naltrexone-bupropion SR
Primary outcome measures
- Total Body Weight Loss (TBWL) at 6 Months % [Time frame: 6-Months]
Secondary outcome measures (9)
- TBWL% at 3 Months [Time frame: 3-months]
- TBWL% at 9 Months [Time frame: 9-Months]
- TBWL% at 12 Months [Time frame: 12-Months]
- TBWL% at 18 Months [Time frame: 18-Months]
- TBWL% at 24 Months [Time frame: 24-Months]
- Degree of Treatment Response [Time frame: 6-Months]
- Cost of Treatment [Time frame: 3, 6, 9, 12, 18, 24 Months]
- Cost-Effectiveness [Time frame: 3, 6, 9, 12, 18, 24 Months]
- Patient Satisfaction [Time frame: 3, 6, 9, 12, 18, 24 Months]
Eligibility criteria
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®).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07728812 · PhenoRxPragmatic2026