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Feasibility of Semaglutide in Advanced Lung Disease

Feasibility of Semaglutide in Advanced Lung Disease

Recruiting
18-80 years
All
Phase 1/2

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Overview

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.

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 details
    Obesity
    Interstitial Lung Disease
    Chronic Obstructive Pulmonary Disease
    Sarcoidosis
    Pulmonary
    Pulmonary Hypertension

NCT05746039

University of Pennsylvania

14 February 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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