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Active, Not Recruiting

NCT Number: NCT06814938

A Study of a Novel Precision Medicine Approach For Obesity

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

2.4 mg subcutaneous weekly

Placebo

Drug

Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly

Primary outcomes

  1. Change in Total Body Weight at 24 weeks

    Time frame: Baseline, 24 weeks

    Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo.

Secondary outcomes

  1. Percentage of Responders >5%

    Time frame: 24 weeks

    Percentage of participants who loss 5% of more of total body weight

  2. Percentage of Responders >10%

    Time frame: 24 weeks

    Percentage of participants who loss 10% of more of total body weight

  3. Percentage of Responders >15%

    Time frame: 24 weeks

    Percentage of participants who loss 15% of more of total body weight

  4. Percentage of Responders >20%

    Time frame: 24 weeks

    Percentage of participants who loss 20% of more of total body weight

  5. Change in Total Body Weight at 3 months

    Time frame: Baseline, 3 months

    Percent change in body weight

  6. Change in Total Body Weight at 6 months

    Time frame: Baseline, 6 months

    Percent change in body weight

  7. Change in Waist Circumference

    Time frame: Baseline, 24 weeks

    Reported in centimeters (CM)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
  • Phenomix Sciences

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 7, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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