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NCT Number: NCT07728812

Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy

A pragmatic, randomized, parallel-arm, controlled study of weight loss outcomes using AOMs guided by MyPhenome test.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®).

Treatment and study plan

Genetic Test

Genetic

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").

Other names: MyPhenome Test

Anti-Obesity Medication (AOM) treatment

Drug

Available AOMs will be: GLP-1 Receptor Agonists (semaglutide or tirzepatide), Phentermine-Topiramate ER, and naltrexone-bupropion SR

Primary outcomes

  1. Total Body Weight Loss (TBWL) at 6 Months %

    Time frame: 6-Months

    TWBL% at 6 months

Secondary outcomes

  1. TBWL% at 3 Months

    Time frame: 3-months

    TBWL% at 3 Months

  2. TBWL% at 9 Months

    Time frame: 9-Months

    TBWL% at 9 Months

  3. TBWL% at 12 Months

    Time frame: 12-Months

    TBWL% at 12 Months

  4. TBWL% at 18 Months

    Time frame: 18-Months

    TBWL% at 18 Months

  5. TBWL% at 24 Months

    Time frame: 24-Months

    TBWL% at 24 Months

  6. Degree of Treatment Response

    Time frame: 6-Months

    6-Months: non-responsive (<3% TBWL), partial responsive (3%-15% TBWL), successful (>15%-20% TBWL) and highly successful (>20% TBWL)

  7. Cost of Treatment

    Time frame: 3, 6, 9, 12, 18, 24 Months

    Cost of Treatment

  8. Cost-Effectiveness

    Time frame: 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.

  9. Patient Satisfaction

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

Phenomix Sciences

Industry

Registry information

Official study title

Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy (PhenoRX Pragmatic Trial)

Acronym: PhenoRXPrag

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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