Feasibility of Semaglutide in Advanced Lung Disease

Sponsor

University of Pennsylvania (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05746039

Collaborator

(none)

Enrollment

Arm

11.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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:

Are patients with advanced lung disease able to tolerate semaglutide therapy?
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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Interstitial Lung Disease Chronic Obstructive Pulmonary Disease Sarcoidosis, Pulmonary Pulmonary Hypertension	Drug: Semaglutide Pen Injector	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Drug (semaglutide) Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy	Drug: Semaglutide Pen Injector Once weekly subcutaneous injection Other Names: Wegovy

Arm

Intervention/Treatment

Experimental: Study Drug (semaglutide)

Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy

Drug: Semaglutide Pen Injector

Once weekly subcutaneous injection

Other Names:

Wegovy

Outcome Measures

Primary Outcome Measures

Tolerability [12 weeks]
The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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