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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether semaglutide, a treatment for diabetes and obesity, can aid people with asthma who have not found relief from inhaled steroids and struggle with obesity. Researchers aim to determine if semaglutide can better control asthma symptoms and reduce airway inflammation. Participants will receive either semaglutide or a placebo to compare outcomes. This trial may suit adults with a history of asthma who currently use inhaled steroids and experience significant asthma symptoms despite treatment. As a Phase 2 trial, this research measures how well semaglutide works in an initial, smaller group, offering participants a chance to contribute to potential advancements in asthma treatment.

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.

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

Research shows that semaglutide is usually well-tolerated, but it can cause some side effects. The most common side effects involve the digestive system, such as nausea and vomiting. For instance, one study found that 74% of patients taking semaglutide experienced these symptoms, although they were mostly mild.

The FDA has already approved semaglutide for treating type 2 diabetes and obesity, indicating thorough safety testing in these conditions. However, using semaglutide for asthma is a new area under study. So far, evidence suggests that while some people may experience stomach-related issues, the treatment is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike the standard treatments for obesity-related asthma, which typically focus on managing symptoms with inhalers or corticosteroids, semaglutide offers a novel approach by targeting the underlying metabolic issues. Semaglutide, originally a diabetes medication, works by mimicking a hormone called GLP-1 that helps regulate appetite and insulin levels, potentially reducing both weight and asthma symptoms. Researchers are excited because semaglutide could address two major health concerns simultaneously, offering a more holistic treatment option for patients.

What evidence suggests that semaglutide might be an effective treatment for obesity-related asthma?

Research has shown that semaglutide, a medication approved for type 2 diabetes and obesity, can help people lose a significant amount of weight. Studies have found that taking 2.4 mg of semaglutide once a week, along with lifestyle changes, leads to lasting weight loss. In this trial, participants will receive either semaglutide or a placebo to evaluate its effects on obesity-related asthma. Being overweight can worsen asthma symptoms because asthma medicines might not work as well. By aiding weight loss, semaglutide may also improve asthma control by reducing airway inflammation. Therefore, for those with obesity-related asthma, semaglutide could be promising as it addresses weight issues and may lead to better asthma management. ^{1 3 6 7 8}

Who Is on the Research Team?

Katherine Cahill, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10999349/

Weight Loss Interventions for Adults with Obesity-Related ... Once weekly cagrilintide 4.5mg in combination with semaglutide 2.4 mg achieved 15.4% (±1.3%) mean weight reduction in a short study period of 26 ...

2. lung.org lung.org/blog/weight-loss-drugs-study

Are Weight Loss Drugs Dangerous for People with Asthma? Being overweight or obese can complicate asthma symptoms, and asthma treatment drugs have been shown to be less efficient for people who are obese.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2032183

Once-Weekly Semaglutide in Adults with Overweight or ... 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05254314

Study Details | NCT05254314 | Glucagon-Like Peptide-1 ... This study will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory ...

5. atsjournals.org atsjournals.org/doi/10.1164/rccm.202406-1166SO

Obesity-related Asthma: A Pathobiology-based Overview of ... Dietary restriction and exercise improve airway inflammation and clinical outcomes in overweight and obese asthma: a randomized trial. Clin ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219823014046

Weight Loss Interventions for Adults With Obesity-Related ... Weight loss can reduce the impact of obesity on asthma and improve patient outcomes by diverse mechanisms including modulating airway inflammation.

7. medcentral.com medcentral.com/endocrinology/diabetes/semaglutide-wins-cv-nod-as-approval-as-the-first-oral-glp-1-for-obesity-nears

Oral Semaglutide Wins Cardiovascular Approval as FDA ... Gastrointestinal adverse events, particularly nausea and vomiting, were more frequent with semaglutide (74.0% vs. 42.2%), though generally mild ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601688/

Clinical Review - Semaglutide (Wegovy) - NCBI Bookshelf - NIH The most common AEs were GI-related, such as nausea (61% of semaglutide patients versus 59% of liraglutide patients versus 22% of placebo patients) and ...