Clinical trial NCT05746039: Feasibility of Semaglutide in Advanced Lung Disease
Official title: Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Obesity
Interstitial Lung Disease
Chronic Obstructive Pulmonary Disease
Sarcoidosis, Pulmonary
Pulmonary Hypertension
Keywords: semaglutide
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Tolerability
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: Baseline to 12 weeks
measure: Body composition
timeFrame: Baseline to 12 weeks
measure: Body composition
timeFrame: Baseline to 12 weeks
measure: Lung function
timeFrame: Baseline to 12 weeks
measure: Lung function
timeFrame: Baseline to 12 weeks
measure: Lung function
timeFrame: Baseline to 12 weeks
measure: Physical function
timeFrame: Baseline to 12 weeks
measure: Physical function
timeFrame: Baseline to 12 weeks
measure: Markers of adiposity and insulin resistance
timeFrame: Baseline to 12 weeks
measure: Markers of adiposity and insulin resistance
timeFrame: Baseline to 12 weeks
measure: Markers of adiposity and insulin resistance
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Perelman School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michaela R Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: