Feasibility of Semaglutide in Advanced Lung Disease
Investigating the Feasibility of Semaglutide in Advanced Lung Disease
Brief description of 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:
- Are patients with advanced lung disease able to tolerate semaglutide therapy?
- 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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Obesity, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Sarcoidosis, Pulmonary, Pulmonary Hypertension
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Age: 18 years - 80 years
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Gender: All
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
This study investigates the feasibility and tolerability of an investigational medication in patients with advanced lung disease. Advanced lung diseases included in the study are interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, and pulmonary hypertension. The purpose of this study is to assess whether patients can tolerate the investigational medication and if it can be adjusted to achieve a target weight.
Participants will undergo various assessments, including pulmonary function tests, physical function tests, and body composition measurements. Blood samples will be collected before and after 12 weeks of therapy. During the treatment period, participants will be asked about any adverse events or side effects they experience.
- Who can participate: Adults aged 18 and older with a BMI over 30 and a diagnosis of interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension requiring supplemental oxygen on exertion can participate. Participants must have a stable treatment regimen for at least 90 days and be on disease-modifying therapy.
- Study details: Participants will receive semaglutide, an investigational medication, for 12 weeks. They will take part in assessments such as pulmonary and physical function tests, as well as body composition measurements. They will also provide blood samples and report any side effects during the 12-week treatment period.
- Study timelines and visits: The study will last 12 weeks. Visits are not specified.
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