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The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease.
The main question[s] it aims to answer are:
Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
This is a small open-label pilot clinical trial of semaglutide in adults (age 18 or older, n=8) with obesity (BMI≥30 kg/m2), and chronic advanced lung disease (interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension requiring supplemental oxygen on exertion). This study will evaluate medication adherence and side effects to determine semaglutide tolerability. Markers of physical function and pulmonary function will be evaluated before therapy and after 12 weeks of therapy to determine the effect of semaglutide on function. Measures of fat and muscle, will be performed before therapy and after 12 weeks of therapy to evaluate how semaglutide alters body composition in this population. Study participants will be monitored for 12 weeks while receiving semaglutide therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug (semaglutide) | Experimental | Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Pen Injector | Drug | Once weekly subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability | The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Change in percent body fat | Baseline to 12 weeks |
| Body composition | Change in skeletal muscle index | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michaela R Anderson, MD | Contact | 215-662-3202 | michaela.anderson@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michaela R Anderson, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Perelman School of Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D017563 | Lung Diseases, Interstitial |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D017565 | Sarcoidosis, Pulmonary |
| D006976 | Hypertension, Pulmonary |
| 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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| Body composition | Change in weight | Baseline to 12 weeks |
| Lung function | Change in forced vital capacity | Baseline to 12 weeks |
| Lung function | Change in forced expiratory volume in 1 second | Baseline to 12 weeks |
| Lung function | Change in diffusion capacity | Baseline to 12 weeks |
| Physical function | Change in frailty as measured by the Short Physical Performance Battery | Baseline to 12 weeks |
| Physical function | Change in six-minute walk distance | Baseline to 12 weeks |
| Markers of adiposity and insulin resistance | Change in c-reactive protein | Baseline to 12 weeks |
| Markers of adiposity and insulin resistance | Change in glycosylated hemoglobin | Baseline to 12 weeks |
| Markers of adiposity and insulin resistance | Change in free fatty acids | Baseline to 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D012507 | Sarcoidosis |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |