Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05746039

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semaglutide Pen Injector

Drug

Once weekly subcutaneous injection

Other names: Ozempic

Primary outcomes

  1. Tolerability

    Time frame: 12 weeks

    The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.

Secondary outcomes

  1. Body composition

    Time frame: Baseline to 12 weeks

    Change in percent body fat

  2. Body composition

    Time frame: Baseline to 12 weeks

    Change in skeletal muscle index

  3. Body composition

    Time frame: Baseline to 12 weeks

    Change in weight

  4. Lung function

    Time frame: Baseline to 12 weeks

    Change in forced vital capacity

  5. Lung function

    Time frame: Baseline to 12 weeks

    Change in forced expiratory volume in 1 second

  6. Lung function

    Time frame: Baseline to 12 weeks

    Change in diffusion capacity

  7. Physical function

    Time frame: Baseline to 12 weeks

    Change in frailty as measured by the Short Physical Performance Battery

  8. Physical function

    Time frame: Baseline to 12 weeks

    Change in six-minute walk distance

  9. Markers of adiposity and insulin resistance

    Time frame: Baseline to 12 weeks

    Change in c-reactive protein

  10. Markers of adiposity and insulin resistance

    Time frame: Baseline to 12 weeks

    Change in glycosylated hemoglobin

  11. Markers of adiposity and insulin resistance

    Time frame: Baseline to 12 weeks

    Change in free fatty acids

Study contacts

Contact information is provided by the study sponsor or research team.

Michaela R Anderson, MD

CONTACT

[email protected]

215-662-3202

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.