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

NCT07728812 | Not Yet Recruiting

• 1 other identifier: PhenoRxPragmatic2026
• Study Type: interventional
• Target: 424
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• Total Body Weight Loss (TBWL) at 6 Months %

  TWBL% at 6 months

  6-Months

Secondary Outcomes (9)

• TBWL% at 3 Months

  3-months

• TBWL% at 9 Months

  9-Months

• TBWL% at 12 Months

  12-Months

• TBWL% at 18 Months

  18-Months

• TBWL% at 24 Months

  24-Months

Study Arms (2)

Standard of Care Medication Selection

ACTIVE COMPARATOR

Patients randomized to this group will be prescribed the medications based on Mayo Clinic Community Internal Medicine Weight Management Program guidelines.

Drug: Anti-Obesity Medication (AOM) treatment

MyPhenome Test

EXPERIMENTAL

Patients randomized to this group will take the MyPhenome Test. Results will be returned and the High CTSGRS (Hungry Brain) phenotype will be assigned to Phentermine-topiramate ER, low CTSGRS (Hungry Gut) phenotype will be assigned to GLP-1 receptor agonists (semaglutide or tirzepatide) and the emotional eating phenotype will be assigned to naltrexone-bupropion SR.

Genetic: Genetic Test; Drug: Anti-Obesity Medication (AOM) treatment

Interventions

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").

Also known as: MyPhenome Test

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

MyPhenome Test; Standard of Care Medication Selection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®).

Sponsors & Collaborators

• Phenomix Sciences: lead

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Genetic Testing; Collagen Type II; Therapeutics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Fibrillar Collagens; Collagen; Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share