University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT05746039
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 1 / Phase 2
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once weekly subcutaneous injection
Other names: Ozempic
Time frame: 12 weeks
The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.
Time frame: Baseline to 12 weeks
Change in percent body fat
Time frame: Baseline to 12 weeks
Change in skeletal muscle index
Time frame: Baseline to 12 weeks
Change in weight
Time frame: Baseline to 12 weeks
Change in forced vital capacity
Time frame: Baseline to 12 weeks
Change in forced expiratory volume in 1 second
Time frame: Baseline to 12 weeks
Change in diffusion capacity
Time frame: Baseline to 12 weeks
Change in frailty as measured by the Short Physical Performance Battery
Time frame: Baseline to 12 weeks
Change in six-minute walk distance
Time frame: Baseline to 12 weeks
Change in c-reactive protein
Time frame: Baseline to 12 weeks
Change in glycosylated hemoglobin
Time frame: Baseline to 12 weeks
Change in free fatty acids
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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