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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05746039
Other study ID # 852967
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 29, 2024
Est. completion date June 28, 2024

Study information

Verified date January 2024
Source University of Pennsylvania
Contact Michaela R Anderson, MD
Phone 215-662-3202
Email michaela.anderson@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date June 28, 2024
Est. primary completion date June 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

Drug:
Semaglutide Pen Injector
Once weekly subcutaneous injection

Locations

Country Name City State
United States University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Body composition Change in percent body fat Baseline to 12 weeks
Secondary Body composition Change in skeletal muscle index Baseline to 12 weeks
Secondary Body composition Change in weight Baseline to 12 weeks
Secondary Lung function Change in forced vital capacity Baseline to 12 weeks
Secondary Lung function Change in forced expiratory volume in 1 second Baseline to 12 weeks
Secondary Lung function Change in diffusion capacity Baseline to 12 weeks
Secondary Physical function Change in frailty as measured by the Short Physical Performance Battery Baseline to 12 weeks
Secondary Physical function Change in six-minute walk distance Baseline to 12 weeks
Secondary Markers of adiposity and insulin resistance Change in c-reactive protein Baseline to 12 weeks
Secondary Markers of adiposity and insulin resistance Change in glycosylated hemoglobin Baseline to 12 weeks
Secondary Markers of adiposity and insulin resistance Change in free fatty acids Baseline to 12 weeks
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