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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4 and week 12
Awards & highlights

GATA-3 Trial Summary

This trial will test whether semaglutide, an FDA-approved diabetes and obesity drug, can improve asthma control in adults who are overweight and not well-controlled with inhaled steroids.

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.Check my eligibility
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.See study design
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.

GATA-3 Trial 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.

GATA-3 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Asthma
The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.
Secondary outcome measures
Asthma
The change in exhaled nitric oxide from semaglutide to week 12.
The change in serum periostin from semaglutide to week 12.
+3 more

GATA-3 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

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.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
868 Previous Clinical Trials
678,540 Total Patients Enrolled
12 Trials studying Asthma
4,215 Patients Enrolled for Asthma
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,281 Previous Clinical Trials
5,488,052 Total Patients Enrolled
58 Trials studying Asthma
11,435 Patients Enrolled for Asthma
Katherine Cahill, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
1 Trials studying Asthma

Media Library

Semaglutide (Glucagon-Like Peptide-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05254314 — Phase 2
Asthma Research Study Groups: Study Drug (Semaglutide), Placebo
Asthma Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05254314 — Phase 2
Semaglutide (Glucagon-Like Peptide-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254314 — Phase 2
~44 spots leftby Nov 2025