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.
• . 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
⁃ 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