Semaglutide for Lung Disease

Recruiting in Palo Alto (17 mi)

Overseen by Michaela R Anderson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Pennsylvania

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michaela R Anderson, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Semaglutide (Glucagon-like peptide-1 receptor agonist)

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.

Participant Groups

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 Canada, Japan for the following indications:

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania