Feasibility of Semaglutide in Advanced Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide Pen Injector.
- Who it may be relevant to
- Registry conditions: Obesity, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Sarcoidosis, Pulmonary. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
Overview
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.
Detailed description
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.
Interventions
- Drug Semaglutide Pen Injector
Once weekly subcutaneous injection
Primary outcome measures
- Tolerability [Time frame: 12 weeks]
Secondary outcome measures (11)
- Body composition [Time frame: Baseline to 12 weeks]
- Body composition [Time frame: Baseline to 12 weeks]
- Body composition [Time frame: Baseline to 12 weeks]
- Lung function [Time frame: Baseline to 12 weeks]
- Lung function [Time frame: Baseline to 12 weeks]
- Lung function [Time frame: Baseline to 12 weeks]
- Physical function [Time frame: Baseline to 12 weeks]
- Physical function [Time frame: Baseline to 12 weeks]
- Markers of adiposity and insulin resistance [Time frame: Baseline to 12 weeks]
- Markers of adiposity and insulin resistance [Time frame: Baseline to 12 weeks]
- Markers of adiposity and insulin resistance [Time frame: Baseline to 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pennsylvania Perelman School of Medicine — Philadelphia
Identifiers
NCT: NCT05746039 · 852967