Feasibility of Semaglutide in Advanced Lung Disease

NCT ID: NCT05746039

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2025-12-28

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.

Conditions

Obesity; Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease; Sarcoidosis, Pulmonary; Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Drug (semaglutide)

Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy

Group Type: EXPERIMENTAL

Semaglutide Pen Injector

Intervention Type: DRUG

Once weekly subcutaneous injection

Interventions

Semaglutide Pen Injector

Once weekly subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Ozempic

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michaela R Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michaela R Anderson, MD

Role: CONTACT

michaela.anderson@pennmedicine.upenn.edu

215-662-3202

Facility Contacts

Apurva Raje

Role: primary

apurva.raje@pennmedicine.upenn.edu

Other Identifiers

852967

Identifier Type: -

Identifier Source: org_study_id