DRUG
Semaglutide
2.4 mg subcutaneous weekly
Status
Active, not recruiting
Phase
Phase 4
Enrollment
135
Locations
2
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
2.4 mg subcutaneous weekly
DRUG
Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly
Timeline
First posted
Feb 7, 2025
Study start
Feb 21, 2025
Primary completion
Dec 2027
Study completion
Nov 2028
Results posted
Not reported
Registry updated
Jul 16, 2026
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.
Percentage of Responders >5%
Time frame · 24 weeks
Percentage of participants who loss 5% of more of total body weight
Percentage of Responders >10%
Time frame · 24 weeks
Percentage of participants who loss 10% of more of total body weight
Percentage of Responders >15%
Time frame · 24 weeks
Percentage of participants who loss 15% of more of total body weight
Percentage of Responders >20%
Time frame · 24 weeks
Percentage of participants who loss 20% of more of total body weight
Change in Total Body Weight at 3 months
Time frame · Baseline, 3 months
Percent change in body weight
Change in Total Body Weight at 6 months
Time frame · Baseline, 6 months
Percent change in body weight
Change in Waist Circumference
Time frame · Baseline, 24 weeks
Reported in centimeters (CM)
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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