Testing a new method to predict obesity treatment response
A Novel Precision Medicine Approach For Obesity: A Randomized, Multi-Center Trial
PHASE4 · Mayo Clinic · NCT06814938
This study is testing if a saliva test can help identify which people with obesity will respond better to the medication semaglutide.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT06814938 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of semaglutide, a medication for obesity, in patients identified by a saliva-based biomarker test called MyPhenome. Participants with obesity will be divided based on their test results for abnormal postprandial satiety, comparing those with a positive test to those with a negative test. The study aims to determine if the biomarker can accurately predict which patients will respond better to the treatment. It is an interventional phase 4 study conducted at the Mayo Clinic.
Who should consider this trial
Good fit: Ideal candidates are individuals with obesity (BMI ≥30 kg/m2) who have controlled chronic conditions.
Not a fit: Patients who have experienced significant weight changes recently or have a history of bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective obesity treatments for patients.
How similar studies have performed: Other studies have shown promise in using biomarkers for treatment response, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida and 1 other locations
- Mayo Clinic in Florida — Jacksonville, Florida, United States (RECRUITING)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Andres Acosta, MD, PhD — Mayo Clinic
- Study coordinator: Megan Schaefer
- Email: Schaefer.Megan@mayo.edu
- Phone: 507-266-6004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity