Obesity & OverweightPhenoRXPragNCT07728812
Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy
A study testing Genetic Test and Anti-Obesity Medication (AOM) treatment in people with Obesity & Overweight, run by Phenomix Sciences.
Trial summary
A pragmatic, randomized, parallel-arm, controlled study of weight loss outcomes using AOMs guided by MyPhenome test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Genetic Test and Anti-Obesity Medication (AOM) treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®).
About this study
Official title: Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy (PhenoRX Pragmatic Trial)
A pragmatic, randomized, parallel-arm, controlled study of weight loss outcomes using AOMs guided by MyPhenome test.
- Conditions
- Obesity & Overweight
- Being tested
- Genetic Test, Anti-Obesity Medication (AOM) treatment
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic TestGenetic
Also called MyPhenome 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").
Anti-Obesity Medication (AOM) treatmentDrug
Available AOMs will be: GLP-1 Receptor Agonists (semaglutide or tirzepatide), Phentermine-Topiramate ER, and naltrexone-bupropion SR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: Genetic Test; Drug: Anti-Obesity Medication (AOM) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Weight Loss (TBWL) at 6 Months %
TWBL% at 6 months
Measured: 6-Months
Secondary outcomes (9)
TBWL% at 3 Months
TBWL% at 3 Months
Measured: 3-months
TBWL% at 9 Months
TBWL% at 9 Months
Measured: 9-Months
TBWL% at 12 Months
TBWL% at 12 Months
Measured: 12-Months
TBWL% at 18 Months
TBWL% at 18 Months
Measured: 18-Months
TBWL% at 24 Months
TBWL% at 24 Months
Measured: 24-Months
Degree of Treatment Response
6-Months: non-responsive (<3% TBWL), partial responsive (3%-15% TBWL), successful (>15%-20% TBWL) and highly successful (>20% TBWL)
Measured: 6-Months
Cost of Treatment
Cost of Treatment
Measured: 3, 6, 9, 12, 18, 24 Months
Cost-Effectiveness
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.
Measured: 3, 6, 9, 12, 18, 24 Months
Patient Satisfaction
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 .
Measured: 3, 6, 9, 12, 18, 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phenomix Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728812
- Sponsor's protocol ID
- PhenoRxPragmatic2026
- Acronym
- PhenoRXPrag
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy (PhenoRX Pragmatic Trial)
- ClinicalTrials.gov ID
- NCT07728812
- Acronym / sponsor ID
- PhenoRXPrag / PhenoRxPragmatic2026
- Conditions
- Obesity & Overweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Phenomix SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pragmatic, randomized, parallel-arm, controlled study of weight loss outcomes using AOMs guided by MyPhenome test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Medication Selection | Active comparator | Drug: Anti-Obesity Medication (AOM) treatmentPatients randomized to this group will be prescribed the medications based on Mayo Clinic Community Internal Medicine Weight Management Program guidelines. |
| MyPhenome Test | Experimental | Genetic: Genetic Test, Drug: Anti-Obesity Medication (AOM) treatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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®).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic TestAlso: MyPhenome TestThe 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"). | Genetic | MyPhenome Test |
| Anti-Obesity Medication (AOM) treatmentAvailable AOMs will be: GLP-1 Receptor Agonists (semaglutide or tirzepatide), Phentermine-Topiramate ER, and naltrexone-bupropion SR | Drug | MyPhenome Test, Standard of Care Medication Selection |
Primary outcome
Total Body Weight Loss (TBWL) at 6 Months %
Time frame: 6-Months
TWBL% at 6 months
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Test and Anti-Obesity Medication (AOM) treatment in people with Obesity & Overweight, run by Phenomix Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Body Weight Loss (TBWL) at 6 Months % (time frame: 6-Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.