Feasibility of Semaglutide in Advanced Lung Disease

Study Overview
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Brief Summary
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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: 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
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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.

Official Title
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Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study

Conditions
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Obesity, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Sarcoidosis, Pulmonary, Pulmonary Hypertension

Intervention / Treatment
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* Drug: Semaglutide Pen Injector


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug (semaglutide)<br>Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy | Drug: Semaglutide Pen Injector<br>* Once weekly subcutaneous injection<br>* Other names: Wegovy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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semaglutide