Obesity Clinical Trial
Official title:
Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
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: 1. Are patients with advanced lung disease able to tolerate semaglutide therapy? 2. Are we able to titrate semaglutide therapy to a target weight? 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.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | June 28, 2024 |
Est. primary completion date | June 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Diagnosis of one of the following lung diseases: interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension - Age > 18 - BMI > 30 kg/m2 - Requires supplemental oxygen on exertion - Stable treatment regimen X 90 days - Use of disease-modifying therapy Exclusion Criteria: - Diabetes - Pregnant or Breastfeeding - Recent weight loss - Recent or chronic GI complaints - History of gastroparesis - History of scleroderma - Hospitalized at time of evaluation - Use of weight loss medication in last 90 days - Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (type 2) - Uncontrolled thyroid disease - History of acute/chronic pancreatitis - Prior suicide attempt - Suicidal ideation in last 90 days - Presence of a pacemaker or defibrillator |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania Perelman School of Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerability | The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight. | 12 weeks | |
Secondary | Body composition | Change in percent body fat | Baseline to 12 weeks | |
Secondary | Body composition | Change in skeletal muscle index | Baseline to 12 weeks | |
Secondary | Body composition | Change in weight | Baseline to 12 weeks | |
Secondary | Lung function | Change in forced vital capacity | Baseline to 12 weeks | |
Secondary | Lung function | Change in forced expiratory volume in 1 second | Baseline to 12 weeks | |
Secondary | Lung function | Change in diffusion capacity | Baseline to 12 weeks | |
Secondary | Physical function | Change in frailty as measured by the Short Physical Performance Battery | Baseline to 12 weeks | |
Secondary | Physical function | Change in six-minute walk distance | Baseline to 12 weeks | |
Secondary | Markers of adiposity and insulin resistance | Change in c-reactive protein | Baseline to 12 weeks | |
Secondary | Markers of adiposity and insulin resistance | Change in glycosylated hemoglobin | Baseline to 12 weeks | |
Secondary | Markers of adiposity and insulin resistance | Change in free fatty acids | Baseline to 12 weeks |
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