Actively Recruiting
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)
Led by Vanderbilt University Medical Center · Updated on 2026-03-05
100
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Male or female 18 years or older
- Obesity defined as BMI �30, or BMI �27 with at least one weight-related comorbidity such as hypertension, dyslipidemia, sleep apnea treatment, pre-diabetes, or cardiovascular disease
- History of physician-diagnosed asthma
- Persistent asthma requiring at least medium-dose daily inhaled corticosteroids
- Symptomatic asthma with an ACQ-6 score of 1.5 or higher at enrollment and randomization
- Stable asthma controller regimen for the prior 8 weeks
- Evidence of bronchodilator responsiveness or airway hyperresponsiveness in the past year
- Female participants of childbearing potential must have a negative pregnancy test at entry
- Female participants of childbearing potential must agree to use highly effective birth control during the study
You will not qualify if you...
- Unable or unwilling to give informed consent or follow study protocol
- Diagnosis of type I or II diabetes or HbA1c �3.5 on screening labs
- Use of more than 8 puffs of short-acting bronchodilators most days in the previous week
- Oxygen saturation below 94% on room air
- Tobacco, e-cigarette, or smoked marijuana use within 12 months, or more than 10 pack-years of smoking history, unless specific conditions are met
- Pregnancy, current breastfeeding, or plans to become pregnant during the study
- Use of pharmaceutical weight loss treatment for more than 7 days in the prior 90 days
- Previous surgical weight loss treatment unless more than 5 years ago with stable or increasing weight
- Personal history of pancreatitis, medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, gallstone disease without gallbladder removal, gastroparesis, or hypersensitivity to semaglutide or local amide anesthetics
- Use of antidiabetic agents other than metformin in the past 90 days
- Use of systemic glucocorticoids in the past 28 days
- Use of monoclonal antibody for asthma treatment in the past 120 days
- Recent serious heart conditions within 1 year
- Other chronic respiratory diseases such as COPD or cystic fibrosis
- History of immune deficiency or malignancy in the past 5 years
- Uncontrolled hypertension or untreated hyperthyroidism
- Current or past drug or alcohol abuse interfering with study compliance
- Use of investigational drugs within 20 weeks prior to participation
- Any medical problems or findings that may increase risk or interfere with study participation
- At randomization: creatinine elevation with low kidney function or less than 80% compliance to baseline asthma inhaler therapy during run-in
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
K
Katherine Cahill, MD
CONTACT
D
Deborah Hunter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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