RecruitingPhase 4

A Study of a Novel Precision Medicine Approach For Obesity

A Novel Precision Medicine Approach For Obesity: A Randomized, Multi-Center Trial

Lead sponsor

Mayo Clinic

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

135

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body weight, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06814938

Org study ID23-006754

Secondary ID1R44DK138619

Timeline

Milestones

Study first posted2025-02-07actual

Study start2025-02-21actual

Last update posted2026-03-02actual

Primary completion2027-12estimated (month precision)

Study completion2028-11estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

- Obesity (BMI ≥30 kg/m2) without or with controlled chronic conditions (e.g., controlled hypertension).

Exclusion criteria

•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

•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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

8 endpoints

Primary/protocol endpoint

Change in Total Body Weight at 24 weeks

Time frame:Baseline, 24 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Responders >5%

Time frame:24 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Responders >10%

Time frame:24 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Responders >15%

Time frame:24 weeks

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Responders >20%

Time frame:24 weeks

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Total Body Weight at 3 months

Time frame:Baseline, 3 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Total Body Weight at 6 months

Time frame:Baseline, 6 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline, 24 weeks

Waist circumference, change

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.