Feasibility of Semaglutide in Advanced Lung Disease

University of Pennsylvania

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Sarcoidosis, Pulmonary; Chronic Obstructive Pulmonary Disease; Obesity; Pulmonary Hypertension; Interstitial Lung Disease

Treatments: Drug: Semaglutide Pen Injector

Study type: Interventional

Funder types: Other

Identifiers

NCT05746039

852967

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Study Drug (semaglutide)

Experimental group

Description:

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

Treatment:

Drug: Semaglutide Pen Injector