What side effects are associated with this type of intervention?

Common treatments for asthma include inhaled corticosteroids, long-acting beta-agonists, leukotriene modifiers, and biologics like mepolizumab. Inhaled corticosteroids can cause oral thrush and hoarseness. Long-acting beta-agonists may lead to increased heart rate and tremors. Leukotriene modifiers can cause headaches and, rarely, mood changes. Biologics like mepolizumab can cause injection site reactions and, in rare cases, anaphylaxis. For GLP-1 receptor agonists like Semaglutide, which are being studied for asthma, known side effects include gastrointestinal issues such as nausea and vomiting, and potential risks of pancreatitis and thyroid tumors.

What prior FDA approvals exist?

The FDA has approved several treatments for asthma, including biologics like dupilumab, which is used for moderate-to-severe asthma and has shown efficacy in reducing oral corticosteroid use and improving asthma control. While GLP-1 receptor agonists like Semaglutide are primarily approved for type 2 diabetes and obesity, they are being studied for their potential benefits in asthma management due to their anti-inflammatory properties. Other FDA-approved asthma treatments include inhaled corticosteroids, long-acting beta-agonists (LABAs), and combination therapies such as inhaled corticosteroids with long-acting muscarinic antagonists (LAMAs) or LABAs.

What other types of research exist?

Promising novel alternatives to Semaglutide for asthma patients include biologics such as Dupilumab, which targets the IL-4 and IL-13 pathways, and Tezepelumab, which targets thymic stromal lymphopoietin (TSLP). Both have shown significant efficacy in reducing asthma exacerbations and improving lung function in clinical trials. Additionally, anti-IL-5 therapies like Mepolizumab and Benralizumab continue to be effective options for severe eosinophilic asthma.

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Glucagon-Like Peptide-1 Receptor Agonist

Semaglutide for Obesity-Related Asthma (GATA-3 Trial)

Phase 2

Recruiting

Led By Katherine Cahill, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current obstructive sleep apnea treatment

History of physician-diagnosed asthma

Must not have

Personal history of gallstone disease without previous cholecystectomy

Diagnosis of type I or type II diabetes mellitus (DM) or HbA1c ≥6.5 on screening labs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 4 and week 12

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Semaglutide may cause digestive problems like nausea or constipation, increase the risk of low blood sugar levels especially when combined with other diabetes medications, potential thyroid tumors including cancer (rare), gallbladder issues such as gallstones, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently being treated for obstructive sleep apnea.

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I have been diagnosed with asthma by a doctor.

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I have asthma symptoms with a score of 1.5 or higher.

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I use a medium or high dose of inhaled steroids daily for my asthma.

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I will use effective birth control during the study.

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I am considered obese with a BMI of 30 or more, or 27 with a weight-related health issue.

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I understand the study and can give my consent.

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I have high blood pressure or have been treated for it in the last year.

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My lung function improves significantly with medication or I react strongly to certain lung tests.

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I have a diagnosed heart or blood vessel disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with diabetes or my HbA1c level is 6.5 or higher.

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I have a chronic lung condition like COPD or cystic fibrosis.

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I have had pancreatitis before.

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I have high blood pressure or untreated thyroid issues.

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I have been on a stable dose of metformin, or haven't used any diabetes medication except metformin in the last 90 days.

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I have not taken any steroids in the last 28 days.

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I have not had cancer, except for non-melanoma skin cancer that was removed, in the last 5 years.

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I've used my rescue inhaler more than 8 times most days last week.

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I or my family have a history of medullary thyroid cancer or MEN2.

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I have used tobacco, e-cigarettes, or smoked marijuana in the last year or for more than 10 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 4 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 4 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 4 and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma

The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.

Secondary study objectives

Asthma

The change in exhaled nitric oxide from semaglutide to week 12.

The change in serum periostin from semaglutide to week 12.

+3 more

Trial Design

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

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for asthma include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), and leukotriene receptor antagonists (LTRAs). ICS reduce airway inflammation, LABAs relax bronchial muscles to improve airflow, and LTRAs block inflammatory chemicals. Semaglutide, a GLP-1 receptor agonist, is being studied for its potential to improve asthma control and reduce airway inflammation, particularly in patients with obesity-related asthma. This matters for asthma patients as it could offer a novel approach to managing symptoms and reducing inflammation, potentially improving overall asthma control.