A Study of a Novel Precision Medicine Approach for Obesity

Launched by MAYO CLINIC · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating obesity using a special test that analyzes saliva. The goal is to see if this saliva test can help predict how well a medication called semaglutide will work for individuals struggling with obesity. Semaglutide is an FDA-approved treatment that can help with weight loss, and researchers want to understand which patients might benefit the most from it.

To participate in the study, individuals should have obesity, indicated by a Body Mass Index (BMI) of 30 or higher, and should be between the ages of 65 and 74. It's important that participants have not lost or gained more than 3% of their body weight in the past three months and do not have a history of certain weight-loss surgeries or untreated mental health issues. If someone is interested in this trial, they can expect regular check-ins and support from healthcare professionals throughout the study. It's also important to know that the trial is currently recruiting participants, and those who qualify will receive a referral for further assistance if any health concerns arise during screening.

Gender

ALL

Eligibility criteria

• 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