Semaglutide for Obesity-Related Asthma

(GATA-3 Trial)

Overseen By Kevin Niswender, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

100 Participants Needed

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.

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

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 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?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 20 patients with type 2 diabetes in Slovenia, oral semaglutide significantly reduced HbA1c levels and fasting plasma glucose, indicating its efficacy in improving glycaemic control.

Patients reported high satisfaction with the treatment, and while some experienced mild gastrointestinal side effects, the overall safety profile was considered good, suggesting that oral semaglutide is a promising option for diabetes management.

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]

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.

Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.

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]

In a phase 3 trial involving 667 adults with overweight or obesity, oral semaglutide 50 mg taken daily resulted in a significant average weight loss of 15.1% compared to only 2.4% with placebo over 68 weeks, demonstrating its efficacy in weight management.

While semaglutide was effective, it was associated with a higher incidence of adverse events, particularly gastrointestinal issues, affecting 80% of participants, indicating that while it is effective, monitoring for side effects is important.

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]

Semaglutide 2.4 mg, administered weekly, can lead to significant weight loss (average 9.6-17.4% of initial body weight) over 68 weeks, improving obesity-related health issues.

While semaglutide is effective, healthcare providers must evaluate patient suitability carefully, considering factors like safety, potential side effects, and individual health conditions.

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]

Once-weekly semaglutide significantly reduced body weight compared to placebo in a meta-analysis of four trials involving 3447 adults with overweight or obesity, demonstrating its efficacy as a weight loss treatment.

Participants receiving semaglutide not only achieved greater weight loss but also showed improvements in waist circumference, body mass index, and overall health-related quality of life compared to those on placebo.

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]

Semaglutide, a GLP-1 receptor agonist, has been shown to produce significant and sustained weight loss in adults with obesity, along with improvements in cardiometabolic risk factors, as demonstrated in the phase 3 STEP trials involving various participants.

The treatment is generally well tolerated, with the most common side effects being mild-to-moderate gastrointestinal issues that are usually temporary and do not require stopping the medication.

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]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

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]

Once-weekly subcutaneous semaglutide 2.4 mg significantly reduces body weight and improves cardiometabolic parameters, such as blood pressure and blood sugar levels, compared to placebo, based on data from the global phase 3 STEP trials involving thousands of participants.

Continued treatment with semaglutide after an initial run-in period further enhances improvements in metabolic health markers, demonstrating its efficacy as a long-term treatment option for obesity and related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Semaglutide, approved by the FDA on June 4, 2021, is the first new drug for chronic weight management in adults with obesity or overweight since 2014, specifically targeting those with a BMI of 27 or greater and at least one weight-related condition.

This medication is intended to be used alongside a weight management program that includes a reduced-calorie diet and increased physical activity, highlighting its role as part of a comprehensive approach to weight loss.

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]

Semaglutide, a glucagon-like peptide-1 receptor agonist, is effective for treating type 2 diabetes and obesity, providing significant weight loss and cardiovascular benefits, making it crucial for high-risk patients.

However, during the SUSTAIN clinical trial program, a safety concern arose regarding the worsening of diabetic retinopathy, potentially linked to rapid reductions in HbA1c levels, which requires further investigation and careful clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.

In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.

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]