NCT05254314 Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)

Trial Parameters

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Brief 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.

Eligibility Criteria

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 * 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 stabl

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