NCT05254314

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 treatment with the study drug for 24 weeks followed by a 2 week final monitoring period.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Semaglutide Pen Injector 2.4mg weekly	Once weekly subcutaneous injection
OTHER	Placebo	Once weekly subcutaneous injection

Timeline

• Start date: 2022-10-11
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2022-02-24
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study