A Study of a Novel Precision Medicine Approach For Obesity
Registered Phase 4 interventional trial (active not recruiting). This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.
Registered clinical trial record on ClinicalTrials.gov (NCT06814938). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: active not recruiting. Study type: interventional. Phase: Phase 4. Sponsor: Mayo Clinic. Conditions: Obesity. Interventions: Semaglutide, Placebo. 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. 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. Primary outcome measures: Change in Total Body Weight at 24 weeks. Eligibility: 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
This is a registered clinical-trial record from ClinicalTrials.gov — a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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