Clinical trial
A Study of a Novel Precision Medicine Approach For Obesity
Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT06814938
Active, not recruitingPhase 4Interventional
What this study is about
This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity
Full registry 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
Treatments and study arms
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
Change in Total Body Weight at 24 weeksBaseline, 24 weeks
Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo.