ObesityPhase 4NCT06814938
A Study of a Novel Precision Medicine Approach For Obesity
A Phase 4 study testing Semaglutide in people with Obesity, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2025to Nov 2028
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obesity (BMI ≥30 kg/m2) without or with controlled chronic conditions (e.g., controlled hypertension).
Who cannot join
- Weight changes greater than 3% in the previous 3 months
- History of bariatric surgery including lap band and bariatric endoscopy
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month.
- Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
- Any contraindication to FDA-approved GLP1R agonists
- A person who is pregnant or wanting to become pregnant
Show all 9Show fewer
- Once the positive or negative cohort is filled at 2:1 ratio, some patients will be screen failed if their gene cohort is full.
- A family member who is enrolled in this study.
- Principal Investigator Discretion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Novel Precision Medicine Approach For Obesity: A Randomized, Multi-Center Trial
This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.
Read the detailed description
The purpose of this study is to test the effectiveness of semaglutide 2.4 mg SQ weekly in patients with obesity with a positive MyPhenome test for abnormal postprandial satiety compared to patients with obesity with a negative MyPhenome test for abnormal postprandial satiety.
- Conditions
- Obesity
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
2.4 mg subcutaneous weekly
PlaceboDrug
Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Group | Experimental | Subjects will take semaglutide weekly for 24 weeks Receives: Drug: Semaglutide |
| Placebo Group | Placebo comparator | Subjects will take placebo weekly for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Body Weight at 24 weeks
Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo.
Measured: Baseline, 24 weeks
Secondary outcomes (7)
Percentage of Responders >5%
Percentage of participants who loss 5% of more of total body weight
Measured: 24 weeks
Percentage of Responders >10%
Percentage of participants who loss 10% of more of total body weight
Measured: 24 weeks
Percentage of Responders >15%
Percentage of participants who loss 15% of more of total body weight
Measured: 24 weeks
Percentage of Responders >20%
Percentage of participants who loss 20% of more of total body weight
Measured: 24 weeks
Change in Total Body Weight at 3 months
Percent change in body weight
Measured: Baseline, 3 months
Change in Total Body Weight at 6 months
Percent change in body weight
Measured: Baseline, 6 months
Change in Waist Circumference
Reported in centimeters (CM)
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start21 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phenomix Sciences
- Responsible party
- Principal investigator, Andres J. Acosta, M.D., Ph.D., Mayo Clinic
- Investigators
- Andres Acosta, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814938
- Sponsor's protocol ID
- 23-006754
- Other IDs
- 1R44DK138619
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Precision Medicine Approach For Obesity: A Randomized, Multi-Center Trial
- ClinicalTrials.gov ID
- NCT06814938
- Acronym / sponsor ID
- 23-006754
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phenomix Sciences
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 7 Feb 2025 (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.
This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.
Detailed description
The purpose of this study is to test the effectiveness of semaglutide 2.4 mg SQ weekly in patients with obesity with a positive MyPhenome test for abnormal postprandial satiety compared to patients with obesity with a negative MyPhenome test for abnormal postprandial satiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Group | Experimental | Drug: SemaglutideSubjects will take semaglutide weekly for 24 weeks |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects will take placebo weekly for 24 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obesity (BMI ≥30 kg/m2) without or with controlled chronic conditions (e.g., controlled hypertension).
Key exclusion criteria (9 listed)
- Weight changes greater than 3% in the previous 3 months
- History of bariatric surgery including lap band and bariatric endoscopy
- Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month.
- Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
- Any contraindication to FDA-approved GLP1R agonists
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 |
|---|---|---|
| Semaglutide2.4 mg subcutaneous weekly | Drug | Semaglutide Group |
| PlaceboLooks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly | Drug | Placebo Group |
Primary outcome
Change in Total Body Weight at 24 weeks
Time frame: Baseline, 24 weeks
Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo.
7 secondary outcomes
Percentage of Responders >5%
Time frame: 24 weeks
Percentage of Responders >10%
Time frame: 24 weeks
Percentage of Responders >15%
Time frame: 24 weeks
Percentage of Responders >20%
Time frame: 24 weeks
Change in Total Body Weight at 3 months
Time frame: Baseline, 3 months
Change in Total Body Weight at 6 months
Time frame: Baseline, 6 months
Change in Waist Circumference
Time frame: Baseline, 24 weeks
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 16 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. This study is not recruiting at the moment.
Andres Acosta, MD, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Obesity, run by Mayo Clinic at 2 sites in United States.
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 1 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Total Body Weight at 24 weeks (time frame: Baseline, 24 weeks). 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 16 Jul 2026.