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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44DK138619 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Phenomix Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide Group | Experimental | Subjects will take semaglutide weekly for 24 weeks |
|
| Placebo Group | Placebo Comparator | Subjects will take placebo weekly for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 2.4 mg subcutaneous weekly |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Body Weight at 24 weeks | Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo. | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders >5% | Percentage of participants who loss 5% of more of total body weight | 24 weeks |
| Percentage of Responders >10% | Percentage of participants who loss 10% of more of total body weight |
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Inclusion Criteria:
- Obesity (BMI ≥30 kg/m2) without or with controlled chronic conditions (e.g., controlled hypertension).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Acosta, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic in Rochester |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Drug |
Looks exactly like the study drug, but it contains no active ingredient administered subcutaneous weekly |
|
| 24 weeks |
| Percentage of Responders >15% | Percentage of participants who loss 15% of more of total body weight | 24 weeks |
| Percentage of Responders >20% | Percentage of participants who loss 20% of more of total body weight | 24 weeks |
| Change in Total Body Weight at 3 months | Percent change in body weight | Baseline, 3 months |
| Change in Total Body Weight at 6 months | Percent change in body weight | Baseline, 6 months |
| Change in Waist Circumference | Reported in centimeters (CM) | Baseline, 24 weeks |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |