Semaglutide for Obesity-Related Asthma

(GATA-3 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Katherine Cahill, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Vanderbilt University Medical Center

Must be taking: Inhaled corticosteroids

Must not be taking: Antidiabetic agents, Glucocorticoids

Disqualifiers: Diabetes, Smoking, Pregnancy, others

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if semaglutide, a diabetes and weight loss drug, can help overweight adults with asthma who still have symptoms despite using inhaled steroids. The medication may reduce lung inflammation and improve breathing. Semaglutide is a drug used for diabetes and weight loss, and it has shown potential in delaying or preventing diabetes onset in individuals with prediabetes and obesity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain medications like systemic glucocorticoids, some antidiabetic agents, or monoclonal antibodies for asthma treatment before joining. Metformin is allowed if the dose is stable.

What data supports the effectiveness of the drug semaglutide for obesity-related asthma?

Semaglutide has been shown to help with significant weight loss in people with obesity, which can improve conditions related to obesity, like type 2 diabetes. This weight loss effect might also help with obesity-related asthma, as losing weight can often improve asthma symptoms. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide has been shown to be generally safe in humans, with common side effects being mild-to-moderate gastrointestinal issues that usually resolve on their own. It has been approved for use in managing type 2 diabetes and weight management, with a safety profile consistent with other similar medications. ^{1 6 7 8 9}

How is the drug semaglutide unique for treating obesity-related asthma?

Semaglutide is unique because it is a once-weekly injection that not only helps with weight loss but also improves cardiometabolic health, which can be beneficial for obesity-related asthma. Unlike other treatments, it offers significant and sustained weight loss, which can help reduce asthma symptoms linked to obesity. ^{3 10 11 12 13}

Research Team

Katherine Cahill, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

Adults with obesity-related asthma who are overweight (BMI ≥30, or ≥27 with weight-related health issues), have a history of physician-diagnosed asthma, and show symptoms despite using inhaled steroids. Participants must not be pregnant, agree to use effective birth control if applicable, and cannot have diabetes or recent significant weight loss treatments. They should also not have used certain drugs for asthma or had pancreatitis.

Inclusion Criteria

I am of childbearing age and have a negative pregnancy test.

I am currently being treated for obstructive sleep apnea.

I have been diagnosed with asthma by a doctor.

Exclusion Criteria

You have had a bad reaction to semaglutide in the past.

Inability or unwillingness of a subject to give written informed consent or comply with the study protocol

I have had gallstones but haven't had my gallbladder removed.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive semaglutide or placebo once weekly for 24 weeks

24 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Semaglutide (Glucagon-Like Peptide-1 Receptor Agonist)

Trial Overview The trial is testing Semaglutide Pen Injector against a placebo to see if it can improve asthma control and reduce airway inflammation in adults with symptomatic asthma linked to obesity. It's randomized so participants won't choose which treatment they get.

Participant Groups

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

Semaglutide 2.4mg once weekly

Group II: Placebo Placebo Group 1 Intervention

Placebo 2.4mg once weekly

Semaglutide is already approved in European Union, United States, Canada, Japan, United States, United States 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vanderbilt University Medical Center Nashville, TN

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Patients Recruited

939,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3361

Patients Recruited

5,516,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. Janić, M., Jovanović, M., Janež, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? Colin, IM., Gérard, KM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Knop, FK., Aroda, VR., do Vale, RD., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of once-weekly semaglutide in adults with overweight or obesity: a meta-analysis. Zhong, P., Zeng, H., Huang, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide for weight management: evidence from the STEP program. Amaro, A., Sugimoto, D., Wharton, S.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk factors efficacy of semaglutide in the STEP program. Amaro, A., Skolnik, NS., Sugimoto, D.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Mares, AC., Chatterjee, S., Mukherjee, D.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide-eye-catching results. Cigrovski Berkovic, M., Strollo, F.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of once-weekly semaglutide in adults with overweight or obesity: a meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide for weight management: evidence from the STEP program. [2023]

8. Belgium pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk factors efficacy of semaglutide in the STEP program. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Semaglutide-eye-catching results. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. [2023]