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A Study of a Novel Precision Medicine Approach For Obesity | Clinical Trials | Clareo Health

RECRUITINGPHASE4

A Study of a Novel Precision Medicine Approach For Obesity

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

NCT06814938•Mayo Clinic

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.

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

February 21, 2025

Primary Completion Date

December 1, 2027

Completion Date

November 1, 2028

Last Updated

March 2, 2026

Enrollment

135

ESTIMATED participants

Conditions

Obesity

Interventions

Semaglutide

DRUG

Placebo

DRUG

Contacts

Megan Schaefer

CONTACT

507-266-6004 Schaefer.Megan@mayo.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of a Novel Precision Medicine Approach For Obesity

Inclusion Criteria

Exclusion Criteria

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