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

NCT05254314 Phase 2 RECRUITING

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.

Details

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2022-10-11
Completion	2026-12

Conditions

• Asthma

Interventions

• Semaglutide Pen Injector 2.4mg weekly
• Placebo

Primary outcomes

• The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity. — Baseline to week 12
  The primary clinical outcome is the difference between the treatment and placebo groups in change from baseline in asthma control questionnaire (ACQ)-7 score to week 12. The ACQ-7 scale ranges from 0-6 with lower scores indicating better asthma control.
• The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity. — Baseline to week 4
  The primary mechanistic outcome is the difference between the treatment and placebo groups in change from baseline in serum periostin at week 4.

Countries

United States