DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06814938

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

2

Recruiting sites

2

Enrollment

135

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

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 1, 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 1, 2026 snapshot.