RecruitingRecruiting
Feasibility of Semaglutide in Advanced Lung Disease
NCT05746039 · University of Pennsylvania
In plain English
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Official title
Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
About this 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 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
Study design
Enrollment target: 8 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-29
Estimated completion: 2027-12-28
Last updated: 2026-04-21
Interventions
Drug: Semaglutide Pen Injector
Primary outcomes
- • Tolerability (12 weeks)
Sponsor
University of Pennsylvania · other
Contacts & investigators
ContactMichaela R Anderson, MD · contact · michaela.anderson@pennmedicine.upenn.edu · 215-662-3202
InvestigatorMichaela R Anderson, MD · principal_investigator, University of Pennsylvania
All locations (1)
University of Pennsylvania Perelman School of MedicineRecruiting
Philadelphia, Pennsylvania, United States