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Feasibility of Semaglutide in Advanced Lung Disease
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.
Conditions:
🦠 Obesity 🦠 Interstitial Lung Disease 🦠 Chronic Obstructive Pulmonary Disease 🦠 Sarcoidosis, Pulmonary 🦠 Pulmonary Hypertension
🗓️ Study Start (Actual) 29 January 2024
🗓️ Primary Completion (Estimated) 28 June 2024
✅ Study Completion (Estimated) 28 June 2024
👥 Enrollment (Estimated) 8
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2023
  • First Submitted that Met QC Criteria 15 February 2023
  • First Posted 27 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 January 2024
  • Last Update Posted 31 January 2024
  • Last Verified January 2024
I'm interested ...!!