Obesity
Conditions
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.
Interventions
DRUGSemaglutide
2.4 mg subcutaneous weekly
DRUGPlacebo
Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly
Sponsors
Mayo Clinic
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phenomix Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Body Weight at 24 weeks | Baseline, 24 weeks | Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders >5% | 24 weeks | Percentage of participants who loss 5% of more of total body weight |
| Percentage of Responders >10% | 24 weeks | Percentage of participants who loss 10% of more of total body weight |
| Percentage of Responders >15% | 24 weeks | Percentage of participants who loss 15% of more of total body weight |
| Percentage of Responders >20% | 24 weeks | Percentage of participants who loss 20% of more of total body weight |
| Change in Total Body Weight at 3 months | Baseline, 3 months | Percent change in body weight |
| Change in Total Body Weight at 6 months | Baseline, 6 months | Percent change in body weight |
| Change in Waist Circumference | Baseline, 24 weeks | Reported in centimeters (CM) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndres Acosta, MD, PhD
Mayo Clinic
Outcome results
None listed