100 Participants Needed

Semaglutide for Obesity-Related Asthma

(GATA-3 Trial)

KW
KC
DH
LB
KN
Overseen ByKevin Niswender, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vanderbilt University Medical Center
Must be taking: Inhaled corticosteroids
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.26111213

Who Is on the Research Team?

KC

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.
See 11 more

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.
See 24 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study Drug (Semaglutide)Experimental Treatment1 Intervention
Semaglutide 2.4mg once weekly
Group II: PlaceboPlacebo Group1 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

Find a Clinic Near You

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

Citations

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]
Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. [2023]
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]
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]
Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. [2023]
Efficacy and safety of once-weekly semaglutide in adults with overweight or obesity: a meta-analysis. [2022]
Efficacy and safety of semaglutide for weight management: evidence from the STEP program. [2023]
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]
Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]
Cardiometabolic risk factors efficacy of semaglutide in the STEP program. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Semaglutide-eye-catching results. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Semaglutide for the treatment of obesity. [2023]
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