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AsthmaPhase 2GATA-3NCT05254314

Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)

A Phase 2 study testing Semaglutide Pen Injector 2.4mg weekly in people with Asthma, run by Vanderbilt University Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Semaglutide Pen Injector 2.4mg weekly
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
11 Oct 2022to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • . Subject must be able to understand and provide informed consent.
  • Males and females age 18 or older
  • Obesity defined as body mass index (BMI) >=30, or >=27 in the setting of >=1 weight-related comorbidity:
  • clinically documented hypertension (>130 mmHg systolic or >85 mmHg diastolic or treatment) in the prior year or during run-in
  • clinically documented dyslipidemia (Triglycerides ш 150 mg/dl, HDL <40 mg/dl in males or <50 mg/dl in females, >=130 mg/dl or treatment) in the prior year or during run-in
  • current obstructive sleep apnea treatment
Show all 15Show fewer
  • documented pre-diabetes defined by A1c 5.7-<6.5 in the prior year or during run-in
  • clinically documented cardiovascular disease
  • History of physician-diagnosed asthma
  • Persistent Asthma as determined by the requirement of at least medium-dose daily inhaled corticosteroid or more
  • Symptomatic asthma with an ACQ-6 score >=1.5 at enrollment and at the time of randomization
  • Patient report of stable asthma controller regimen for the prior 8 weeks
  • Evidence of bronchodilator responsiveness (>=12% and at least 200 mL increase in FEV1) or airway hyperresponsiveness with a Methacholine PC20 <=16 mg/mL or PD20 <=400 mcg in the prior year
  • Female subjects of childbearing potential must have a negative pregnancy test upon study entry
  • Female subjects of childbearing potential must agree to use a highly effective birth control method (e.g. hormonal, surgical or abstinence) for the duration of the study

Who cannot join

  • At enrollment:
  • Inability or unwillingness of a subject to give written informed consent or comply with the study protocol
  • Diagnosis of type I or type II diabetes mellitus (DM) or HbA1c ≥6.5 on screening labs
  • Use of >8 puffs/inhalations of short-acting bronchodilators most days in the previous week (i.e. answer to question #6 on ACQ-6 = 4, 5, or 6)
  • Oxygen saturation < 94% on room air
  • Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months#, or >10 pack-years of use*
Show all 40Show fewer
  • Can still be enrolled if ≥40 years old, smoked <20 pack years, none within 12 months#, and demonstrate a post-bronchodilator FEV1/FVC ratio of >0.7 or a DLCO z-score of -1.645 or greater (or the equivalent ≥ 75% of predicted) documented in prior 12 months or during run-in
  • Smoking equivalent pack years. One pack of cigarettes a day for 1 year is equivalent to:
  • 1 cigar or pipe per day for 1 year
  • Smoked hookah or shisha =1 session per day for 1 year
  • Vaped e-cigarettes =0.5 mLs e-liquid per day for 1 year, or =1 cartridge/tank/pod per day for 1 year
  • 1 use of inhaled marijuana per day for 1 year
  • #Use of any inhalant >1 time weekly in the past year is considered use within 12 months.
  • Active smoking of conventional tobacco, inhaling of marijuana or other drugs, or vaping of e-cigarettes or vape pods >1 time per week in the past year.
  • Any form of tobacco qualifies, such as: 1 cigarette, 1 hookah or shisha sessions, 1 cigar, 1 pipe, etc.
  • Any electronic (e)-device included: e-cigarette e-cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods, etc.
  • Any form of inhaled marijuana, including smoking marijuana leaves or inhaling THC via e-cigarette or device
  • Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period
  • Pharmaceutical weight loss treatment for >7 days in the prior 90 days at enrollment
  • Previous surgical weight loss treatment. Can still be enrolled if surgery > 5 years ago and evidence of stable or increasing weight in the prior 3-12 months.
  • Personal history of pancreatitis as determined by history
  • Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2
  • Personal history of gallstone disease without previous cholecystectomy
  • Personal history of gastroparesis
  • Personal history of hypersensitivity to semaglutide
  • Personal history of hypersensitivity to local amide type (ex. Lidocaine) anesthetics
  • Use of antidiabetic agent, other than metformin, including GLP-1R agonist in the previous 90 days. Metformin is allowed provided the dose has been stable in the 90 days prior to screening and will remain stable for the duration of the trial.
  • Use of systemic glucocorticoids in the past 28 days
  • Use of monoclonal antibody for the treatment of asthma in the past 120 days
  • Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history
  • Patient report and confirmed by review of historical diagnostic testing by study physician of other physician-diagnosed chronic respiratory diseases: COPD, cystic fibrosis, pulmonary hypertension, interstitial lung disease, sarcoidosis, bronchiectasis
  • History of physician-diagnosed immune deficiency.
  • History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years.
  • Current uncontrolled hypertension (systolic >150, diastolic >90) or untreated hyperthyroidism
  • Current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
  • Use of investigational drugs within 20 weeks of participation, other than vaccines and/or treatments for SARS-CoV-2 authorized for emergency use
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
  • At randomization:
  • Screening creatinine elevation with EGFR<30 ml/min/1.73 m2 collected at visit 1a
  • Compliance to baseline asthma inhaler therapy of <80% during run-in, at the time of randomization.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Glucagon-Like Peptide-1 Receptor Agonist Treatment in Adult, Obesity-related, Symptomatic Asthma (GATA-3)

This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. This study will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory tract in adult asthma associated with obesity.

Read the detailed description

This is a proof-of-principal randomized, double-blind, placebo-controlled, single-site clinical trial of semaglutide in adult (age 18 or older, n=100), obesity-related (BMI≥30), symptomatic asthma without type II diabetes. This study will monitor clinical asthma symptom and quality of life questionnaires and airway function to determine the effect of semaglutide on asthma control. Markers of respiratory tract and adipose tissue inflammation will be monitored to determine the effect of semaglutide on airway inflammation. Study participants will be monitored for 4 weeks before assignment to treatment with the study drug for 24 weeks followed by a 2 week final monitoring period.

Conditions
Asthma
Being tested
Semaglutide Pen Injector 2.4mg weekly, Placebo
Keywords
Asthma, Obesity, Semaglutide, Glucagon-like peptide-1 receptor agonist, www.tnasthmaobesitystudy.com
Medical subject headings
Asthma, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide Pen Injector 2.4mg weeklyDrug

    Also called Wegovy

    Once weekly subcutaneous injection

  • PlaceboOther

    Once weekly subcutaneous injection

Study groups in NCT05254314
Study groupRoleWhat they receive
Study Drug (Semaglutide)ExperimentalSemaglutide 2.4mg once weekly
Receives: Drug: Semaglutide Pen Injector 2.4mg weekly
PlaceboPlacebo comparatorPlacebo 2.4mg once weekly
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity.

    The primary clinical outcome is the difference between the treatment and placebo groups in change from baseline in asthma control questionnaire (ACQ)-7 score to week 12. The ACQ-7 scale ranges from 0-6 with lower scores indicating better asthma control.

    Measured: Baseline to week 12

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

    The primary mechanistic outcome is the difference between the treatment and placebo groups in change from baseline in serum periostin at week 4.

    Measured: Baseline to week 4

Secondary outcomes (6)

  1. The impact of semaglutide on weight loss over time.

    The change from baseline in weight to week 24.

    Measured: Baseline to week 24

  2. The efficacy of semaglutide once weekly on asthma control questionnaire-6 score in subjects with symptomatic, persistent asthma and obesity

    The change from baseline in ACQ-6 score to week 12. The ACQ-6 scale ranges from 0-6 with lower scores indicating better asthma control.

    Measured: Baseline to week 12

  3. The maximal dose of semaglutide tolerated in persistent asthma with obesity.

    The maximum tolerated dose of the investigational product at week 24.

    Measured: Baseline to week 24

  4. Incidence of treatment-emergent adverse events from semaglutide in persistent asthma with obesity.

    The treatment-emergent adverse events from first dose to the completion of follow up at week 26.

    Measured: Baseline to week 26

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

    The change from baseline in exhaled nitric oxide at weeks 4 and 12.

    Measured: Baseline to week 4 and week 12

  6. The change in serum periostin from semaglutide to week 12.

    The change from baseline in serum periostin at week 12.

    Measured: Baseline to week 4 and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2022
  2. Study start11 Oct 2022
  3. Primary completion28 Sep 2026
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05254314
Sponsor's protocol ID
DAIT-U01-VAN-003
Other IDs
U01AI155299
Acronym
GATA-3
Status last verified
Sep 2026
First submitted
14 Feb 2022
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Tomasello A, Bacharier LB, Becker PM, Dempsey C, Wu P, Peebles RS, Niswender K, Dupont WD, Bernard G, Cahill KN. Untangling obese asthma: Design of proof-of-concept study of semaglutide in poorly controlled asthma. J Allergy Clin Immunol Glob. 2025 Dec 17;5(2):100627. doi: 10.1016/j.jacig.2025.100627. eCollection 2026 Mar.

    PubMed 41567689

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide Pen Injector 2.4mg weekly in people with Asthma, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity. (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05254314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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