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NCT05746039 | RECRUITING | Obesity


Feasibility of Semaglutide in Advanced Lung Disease
Sponsor:

University of Pennsylvania

Brief Summary:

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.

Condition or disease

Obesity

Interstitial Lung Disease

Chronic Obstructive Pulmonary Disease

Sarcoidosis, Pulmonary

Pulmonary Hypertension

Intervention/treatment

Semaglutide Pen Injector

Phase

PHASE1

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 8 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
Actual Study Start Date : 2024-01-29
Estimated Primary Completion Date : 2025-12-28
Estimated Study Completion Date : 2025-12-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Feasibility of Semaglutide in Advanced Lung Disease

Location Details

NCT05746039


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Locations


RECRUITING

United States, Pennsylvania

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States, 19104

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