Feasibility of Semaglutide in Advanced Lung Disease

April 16, 2026 updated by: University of Pennsylvania

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Drug (semaglutide)
Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy
Drug: Semaglutide Pen Injector
Once weekly subcutaneous injection
Other Names:
  • Ozempic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Baseline to 12 weeks
Change in percent body fat
Baseline to 12 weeks
Body composition
Time Frame: Baseline to 12 weeks
Change in skeletal muscle index
Baseline to 12 weeks
Body composition
Time Frame: Baseline to 12 weeks
Change in weight
Baseline to 12 weeks
Lung function
Time Frame: Baseline to 12 weeks
Change in forced vital capacity
Baseline to 12 weeks
Lung function
Time Frame: Baseline to 12 weeks
Change in forced expiratory volume in 1 second
Baseline to 12 weeks
Lung function
Time Frame: Baseline to 12 weeks
Change in diffusion capacity
Baseline to 12 weeks
Physical function
Time Frame: Baseline to 12 weeks
Change in frailty as measured by the Short Physical Performance Battery
Baseline to 12 weeks
Physical function
Time Frame: Baseline to 12 weeks
Change in six-minute walk distance
Baseline to 12 weeks
Markers of adiposity and insulin resistance
Time Frame: Baseline to 12 weeks
Change in c-reactive protein
Baseline to 12 weeks
Markers of adiposity and insulin resistance
Time Frame: Baseline to 12 weeks
Change in glycosylated hemoglobin
Baseline to 12 weeks
Markers of adiposity and insulin resistance
Time Frame: Baseline to 12 weeks
Change in free fatty acids
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Michaela R Anderson, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2027

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 852967

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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