Feasibility of Semaglutide in Advanced Lung Disease

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746039
• Other study ID #: 852967
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Obesity
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension
• Sarcoidosis
• Sarcoidosis, Pulmonary

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