A Study of a Novel Precision Medicine Approach for Obesity

Last updated: February 21, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

4

Condition

Obesity

Diabetes Prevention

Treatment

Placebo

Semaglutide

Clinical Study ID

NCT06814938
23-006754
1R44DK138619
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 HospitalAnxiety 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 >11or difficulties with substance or eating disorders, the participant will be excludedand given a referral letter to his/her primary care doctor for further appraisal andfollow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during thepatient'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 bescreen failed if their gene cohort is full.

  • A family member who is enrolled in this study.

  • Principal Investigator Discretion

Study Design

Total Participants: 135
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
February 21, 2025
Estimated Completion Date:
November 30, 2028

Study 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.

Connect with a study center

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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