Feasibility of Semaglutide in Advanced Lung Disease

Phase 1

Recruiting

• Conditions: Obesity; Sarcoidosis, Pulmonary; Pulmonary Hypertension; Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Semaglutide Pen Injector

• Registration Number: NCT05746039
• Lead Sponsor: University of Pennsylvania

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:

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.

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 Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Study Start: 2024-01-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-12-28
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Drug (semaglutide)	Semaglutide Pen Injector	Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Body composition	Baseline to 12 weeks	Change in weight
Lung function	Baseline to 12 weeks	Change in diffusion capacity
Physical function	Baseline to 12 weeks	Change in six-minute walk distance
Markers of adiposity and insulin resistance	Baseline to 12 weeks	Change in free fatty acids

Trial Locations

Locations (1)

University of Pennsylvania Perelman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States