A Study of a Novel Precision Medicine Approach For Obesity

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.

Key facts

Study ID

NCT06814938

Run by

Mayo Clinic

People needed

135

Starts

2025-02-21

Expected to finish

2028-11-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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