Semaglutide for Lung Disease

Overseen By Michaela R Anderson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Pennsylvania

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Pregnancy, Gastroparesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether semaglutide, a drug already used for diabetes and obesity, can be safely administered to individuals with serious lung diseases. Researchers aim to determine if patients can tolerate the drug and if it aids in achieving a specific weight. The trial targets individuals diagnosed with lung diseases such as COPD or pulmonary hypertension, who have a BMI over 30 and require supplemental oxygen during activity. Participants will undergo tests and surveys to monitor side effects throughout the 12-week treatment. As a Phase 1 and Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it requires that your treatment regimen has been stable for 90 days, which suggests you may need to continue your current medications.

Is there any evidence suggesting that semaglutide is likely to be safe for humans?

Research has shown that semaglutide is generally safe for people with diabetes and obesity, where it's already approved for use. Some studies suggest it might also reduce the risk of lung diseases, benefiting those with lung problems. However, semaglutide can have serious side effects. For instance, one study found that 9.8% of participants taking semaglutide experienced serious health issues, compared to 6.4% of those on a placebo.

Semaglutide can also slow stomach emptying, increasing the risk of leftover food in the stomach and potentially leading to problems like accidentally inhaling food into the lungs. While semaglutide shows promise, there are risks to consider. Always consult a doctor before deciding to join a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about semaglutide for lung disease because it offers a novel approach compared to standard treatments. Most current options for lung diseases focus on reducing inflammation or dilating airways, but semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, traditionally used for diabetes and weight management. This treatment works by influencing metabolic pathways, which could potentially lead to improved lung function and overall health. Additionally, semaglutide is administered via a convenient once-weekly subcutaneous injection, which is less burdensome compared to daily medication regimens. This unique mechanism and delivery method open new possibilities for managing lung disease effectively.

What evidence suggests that semaglutide might be an effective treatment for advanced lung disease?

Studies have shown that semaglutide, a medication approved for treating diabetes and obesity, can reduce the risk of lung diseases by 18%. Research with mice has explored how semaglutide might improve lung health by affecting certain proteins. In addition to aiding weight loss and diabetes management, semaglutide has also been shown to lower the risk of serious heart problems. These findings suggest potential benefits for lung health, but more research is needed to confirm this in people with lung disease. Participants in this trial will receive semaglutide to further investigate its potential benefits for lung health. ^{2 5 6 7 8}

Who Is on the Research Team?

Michaela R Anderson, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a BMI above 30 who have advanced lung diseases like interstitial lung disease, sarcoidosis, COPD, or pulmonary hypertension. They should need extra oxygen when active and have been on stable treatment for the last 90 days.

Inclusion Criteria

I need extra oxygen when I move around.

BMI > 30 kg/m2

You have been receiving treatment with regimen X for at least 90 days.

Exclusion Criteria

I am currently in the hospital.

I or my family have a history of medullary thyroid cancer or MEN type 2.

I have a history of pancreatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide therapy for 12 weeks with weekly subcutaneous injections

12 weeks

Weekly visits for injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The study tests if semaglutide, usually used for diabetes and obesity, is safe and manageable for patients with severe lung conditions. It checks their ability to tolerate the drug and reach target weight loss over a period of 12 weeks.

How Is the Trial Designed?

Group I: Study Drug (semaglutide) Experimental Treatment 1 Intervention

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

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942255/

Effect of Semaglutide and Empagliflozin on Pulmonary ... This study utilized proteomics to investigate changes in protein expression associated with lung health in obese mice exposed to semaglutide and empagliflozin ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10369734/

The relationship between the use of GLP-1 receptor ... Semaglutide, Liraglutide and Dulaglutide reduce the risk of respiratory diseases by 18%, 14% and 18%, respectively. Trial duration, control ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01375-3/fulltext

Semaglutide and cardiovascular outcomes by baseline ... Semaglutide significantly reduced MACE incidence compared with placebo among 17 604 patients enrolled in SELECT, with consistent benefits across ...

4. diabetesjournals.org diabetesjournals.org/care/article/47/10/1834/157059/Real-World-Use-of-Semaglutide-for-Weight

Real-World Use of Semaglutide for Weight Management More recently, semaglutide has also demonstrated a notable 20% decrease in risk of major cardiovascular events in patients with overweight or ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05746039?cond=%22Lung%20Disease%22&intr=%22glucagon-like%20peptide-1%20receptor%20agonists%22&viewType=Table&rank=1

Feasibility of Semaglutide in Advanced Lung Disease An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11790292/

Semaglutide: Double-edged Sword with Risks and Benefits Semaglutide therapy has adverse anesthetic risks due to delayed gastric emptying resulting in potential for residual gastric content and pulmonary aspiration ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1607141

Semaglutide and Cardiovascular Outcomes in Patients ... The primary outcome occurred in 108 of 1648 patients (6.6%) in the semaglutide group and in 146 of 1649 patients (8.9%) in the placebo group ( ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000299

Weight loss outcomes, tolerability, side effects, and risks Similarly, participants taking semaglutide experienced a higher number of serious adverse events (9.8 %) compared to participants taking placebo (6.4 %). In ...