RightFit
RecruitingPhase 1 / Phase 2

Feasibility of Semaglutide in Advanced Lung Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Study participants will be monitored for 12 weeks while receiving semaglutide therapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether people with advanced lung disease can take semaglutide and handle its side effects for 12 weeks. Semaglutide is approved by the FDA for diabetes and obesity. Researchers also want to see if they can adjust the dose to reach a target weight.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have one of these lung diseases: interstitial lung disease (lung scarring), sarcoidosis (swelling that can affect the lungs), COPD (a disease that limits airflow), or pulmonary hypertension (high blood pressure in lung blood vessels).
  • Be older than 18.
  • Have a BMI over 30. BMI is a measure of weight compared with height.
  • Need extra oxygen during physical activity.
  • Have had a stable treatment plan for 90 days.
  • Use medicine that helps change the course of your lung disease.

Who can't join

  • Have diabetes, or are pregnant or breastfeeding.
  • Have recent weight loss, or have used weight-loss medicine in the last 90 days.
  • Have recent or ongoing stomach or bowel problems, or a history of gastroparesis (slow stomach emptying).
  • Have a history of scleroderma (a disease that hardens skin and other tissues) or pancreatitis (swelling of the pancreas).
  • Are in the hospital when checked for the study.
  • Have uncontrolled thyroid disease, or a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (a condition that causes tumors in hormone-making glands).
  • Have ever attempted suicide or had thoughts of suicide in the last 90 days.
  • Have a pacemaker or defibrillator (a device that helps control your heartbeat).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

PA