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| ID | Type | Description | Link |
|---|---|---|---|
| Pending | Other Identifier | Pending |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| The Metis Foundation | OTHER |
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Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pubertal Adolescent - Continuous Treatment | Experimental | Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 32 weeks of semaglutide (s.c.) |
|
| Pubertal Adolescent - Early Treatment Cessation | Experimental | Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo |
|
| Post-Pubertal Adolescent - Continuous Treatment | Experimental | Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 32 weeks of semaglutide (s.c.) |
|
| Post-Pubertal Adolescent - Early Treatment Cessation | Experimental | Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo |
|
| Adult - Continuous Treatment | Active Comparator | Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide 1.7mg subcutaneous | Drug | Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood oxygen-level dependent signal | measured via resting-state functional magnetic resonance imaging | From enrollment to the end of trial at 32 weeks |
| meal kilocalories (kcal) | Measured as kcal consumed from standardized ad libitum meal | From enrollment to the end of trial at 32 weeks |
| visual analogue scale (VAS) score for hunger | pre- and post-meal hunger measured on a 100mm VAS | From enrollment to the end of trial at 32 weeks |
| visual analogue scale (VAS) for desire to eat | pre- and post-meal desire to eat measured on a 100mm VAS | From enrollment to end of trial at 32 weeks |
| visual analogue scale (VAS) score for fullness | pre- and post-meal feeling of fullness measured on a 100mm VAS | From enrollment to end of trial at 32 weeks |
| visual analogue scale (VAS) score for amount participant feels they can eat | pre- and post-meal of amount participant feels they can eat measured on a 100mm VAS | From enrollment to end of trial at 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Shapiro, PhD, MPH | Contact | 3037241150 | allison.shapiro@cuanschutz.edu | |
| Sean Nilan | Contact | thomas.nilan@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allison Shapiro, PhD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
Pending consent authorization by participants
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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study statistician
|
| Adult - Early Treatment Cessation | Active Comparator | Adults defined as 30-45 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo |
|
|
| Placebo | Drug | Placebo saline solution subcutaneous |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |