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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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The purpose of this study to understand better how this anti-obesity medication works to assist individuals to lose weight and maintain weight loss. This study may lead to the development of other related medications for assisting people with the disease of obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | Will receive active medication semaglutide subcutaneously, once weekly, self-injection. Month 1 - 0.24 mg SC once weekly x 4 weeks.(IE-1) Month 2- 0.5 mg SC once weekly x 4 weeks.(IE-2) Month 3 -1 mg SC once weekly x 4 weeks.(IE-3) Month 4 - 1.7 mg SC once weekly x 4 weeks.(IE-4) Month 5 - 2.4 mg SC once weekly x 4 weeks. (IE-5) Month 6 - 2.4 mg SC continue once weekly x 8 weeks.(IE-6) Month 7 - completion visit (IE-7) |
|
| Control Group | Placebo Comparator | Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 2.4mg | Drug | The intervention drug, semaglutide 2.4mg will be given to the Intervention Group per the schedule outlined in the armed description. |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of weight loss. | Assessment will be based on pounds lost between baseline and final study visit. | Change between baseline and final study visit, seven months post baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Food Addiction Assessment | Yale Food Addiction Scale Survey administered to subjects at baseline and month four of treatment. Assessment results based on multiple survey questions regarding intake of specific food types (sugar, starch, sweet, salty, savory). | Change between baseline and month four of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Peters, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92350 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 18, 2025 | Sep 4, 2025 | 9 | ||
| Apr 27, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D000077962 | Body-Weight Trajectory |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Placebo | Drug | A placebo will be given to the control group per the schedule outlined in the armed description. |
|
| May 18, 2026 |
| 10 |
| May 26, 2026 | Jun 22, 2026 | 11 |
| Jun 23, 2026 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |