A Novel Precision Medicine Approach For Obesity: A Randomized, Multi-Center Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Change in Total Body Weight at 24 weeks
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo Group
Subjects will take placebo weekly for 24 weeks.
Intervention: Placebo (Drug)
Semaglutide Group
Subjects will take semaglutide weekly for 24 weeks
Intervention: Semaglutide (Drug)
Outcomes
Primary Outcomes
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
- Percentage of Responders >5%(24 weeks)
- Percentage of Responders >10%(24 weeks)
- Percentage of Responders >15%(24 weeks)
- Percentage of Responders >20%(24 weeks)
- Change in Total Body Weight at 3 months(Baseline, 3 months)
- Change in Total Body Weight at 6 months(Baseline, 6 months)
- Change in Waist Circumference(Baseline, 24 weeks)
Investigators
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic