ObesityPhase 1/2NCT05746039
Feasibility of Semaglutide in Advanced Lung Disease
A Phase 1/2 study testing Semaglutide Pen Injector in people with Obesity and Interstitial Lung Disease, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Semaglutide Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 28 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes
- Pregnant or Breastfeeding
- Recent weight loss
- Recent or chronic GI complaints
- History of gastroparesis
- History of scleroderma
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Apurva Raje, apurva.raje@pennmedicine.upenn.edu
About this study
Official title: 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:
- Are patients with advanced lung disease able to tolerate semaglutide therapy?
- 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.
Read the 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
- Being tested
- Semaglutide Pen Injector
- Keywords
- semaglutide
- Medical subject headings
- Obesity, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Sarcoidosis, Pulmonary, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen InjectorDrug
Also called Ozempic
Once weekly subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Study Drug (semaglutide) | Experimental | Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy Receives: Drug: Semaglutide Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.
Measured: 12 weeks
Secondary outcomes (11)
Body composition
Change in percent body fat
Measured: Baseline to 12 weeks
Body composition
Change in skeletal muscle index
Measured: Baseline to 12 weeks
Body composition
Change in weight
Measured: Baseline to 12 weeks
Lung function
Change in forced vital capacity
Measured: Baseline to 12 weeks
Lung function
Change in forced expiratory volume in 1 second
Measured: Baseline to 12 weeks
Lung function
Change in diffusion capacity
Measured: Baseline to 12 weeks
Physical function
Change in frailty as measured by the Short Physical Performance Battery
Measured: Baseline to 12 weeks
Physical function
Change in six-minute walk distance
Measured: Baseline to 12 weeks
Markers of adiposity and insulin resistance
Change in c-reactive protein
Measured: Baseline to 12 weeks
Markers of adiposity and insulin resistance
Change in glycosylated hemoglobin
Measured: Baseline to 12 weeks
Markers of adiposity and insulin resistance
Change in free fatty acids
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start29 Jan 2024
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michaela R Anderson, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746039
- Sponsor's protocol ID
- 852967
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT05746039
- Acronym / sponsor ID
- 852967
- Conditions
- Obesity, Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Sarcoidosis, Pulmonary, Pulmonary Hypertension
- Keywords
- semaglutide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are patients with advanced lung disease able to tolerate semaglutide therapy?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Drug (semaglutide) | Experimental | Drug: Semaglutide Pen InjectorSemaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- Diabetes
- Pregnant or Breastfeeding
- Recent weight loss
- Recent or chronic GI complaints
- History of gastroparesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen InjectorAlso: OzempicOnce weekly subcutaneous injection | Drug | Study Drug (semaglutide) |
Primary outcome
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.
11 secondary outcomes
Body composition
Time frame: Baseline to 12 weeks
Body composition
Time frame: Baseline to 12 weeks
Body composition
Time frame: Baseline to 12 weeks
Lung function
Time frame: Baseline to 12 weeks
Lung function
Time frame: Baseline to 12 weeks
Lung function
Time frame: Baseline to 12 weeks
Physical function
Time frame: Baseline to 12 weeks
Physical function
Time frame: Baseline to 12 weeks
Markers of adiposity and insulin resistance
Time frame: Baseline to 12 weeks
Markers of adiposity and insulin resistance
Time frame: Baseline to 12 weeks
Markers of adiposity and insulin resistance
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michaela R Anderson, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Semaglutide Pen Injector in people with Obesity and Interstitial Lung Disease, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaela R Anderson, MD (215-662-3202, michaela.anderson@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.