Semaglutide for Obesity-Related Asthma
This study is testing if semaglutide (a medication approved for type 2 diabetes and obesity) can improve asthma control and reduce airway inflammation in adults with asthma and obesity. You might be able to join if you are 18 or older, have asthma symptoms despite using inhaled steroids, and have obesity (a body mass index or BMI of 30 or higher, or 27 or higher with certain weight-related health issues like high blood pressure). The study will look at how semaglutide affects your asthma symptoms and quality of life, as well as markers of inflammation in your airways. This study is currently recruiting 100 participants.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either semaglutide or a placebo (an inactive substance), and neither you nor your doctor will know which you are receiving. It involves 100 adult participants.
- What's involved
- You would be monitored for 4 weeks before starting treatment, then receive weekly injections of semaglutide or placebo for 24 weeks. This is followed by a 2-week final monitoring period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for 2 weeks after the 24-week treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05254314
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentVanderbilt University Medical CenterInvestigator-initiated
~100 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Semaglutide Pen Injector 2.4mg weeklyPlacebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity.
Measured over Baseline to week 12
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Katherine Cahill, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
documented pre-diabetes defined by A1c 5.7-\<6.5 in the prior year or during run-in
clinically documented cardiovascular disease 4. History of physician-diagnosed asthma 5. Persistent Asthma as determined by the requirement of at least medium-dose daily inhaled corticosteroid or more 6. Symptomatic asthma with an ACQ-6 score \>=1.5 at enrollment and at the time of randomization 7. Patient report of stable asthma controller regimen for the prior 8 weeks 8. 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 9. Female subjects of childbearing potential must have a negative pregnancy test upon study entry 10. 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
Exclusion
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
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
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 6. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period 7. Pharmaceutical weight loss treatment for \>7 days in the prior 90 days at enrollment 8. 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. 9. Personal history of pancreatitis as determined by history 10. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2 11. Personal history of gallstone disease without previous cholecystectomy 12. Personal history of gastroparesis 13. Personal history of hypersensitivity to semaglutide 14. Personal history of hypersensitivity to local amide type (ex. Lidocaine) anesthetics 15. 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. 16. Use of systemic glucocorticoids in the past 28 days 17. Use of monoclonal antibody for the treatment of asthma in the past 120 days 18. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history 19. 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 20. History of physician-diagnosed immune deficiency. 21. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years. 22. Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism 23. 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. 24. Use of investigational drugs within 20 weeks of participation, other than vaccines and/or treatments for SARS-CoV-2 authorized for emergency use 25. 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.
What this trial measures
- The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity.Baseline to week 12
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.
- The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.Baseline to week 4
The primary mechanistic outcome is the difference between the treatment and placebo groups in change from baseline in serum periostin at week 4.