Glucagon-Like Peptide-1 Receptor Agonist Treatment in Adult, Obesity-related, Symptomatic Asthma (GATA-3)
Vanderbilt University Medical Center
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. 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.
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 trea…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. . Subject must be able to understand and provide informed consent. 2. Males and females age 18 or older 3. 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…
Interventions
- DrugSemaglutide Pen Injector 2.4mg weekly
Once weekly subcutaneous injection
- OtherPlacebo
Once weekly subcutaneous injection
Location
- Vanderbilt University Medical CenterNashville, Tennessee