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RECRUITINGPHASE2

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)

NCT05254314•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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Exclusion Criteria

•At enrollment:
•1. Inability or unwillingness of a subject to give written informed consent or comply with the study protocol
•2. Diagnosis of type I or type II diabetes mellitus (DM) or HbA1c ≥6.5 on screening labs
•3. Use of \>8 puffs/inhalations of short-acting bronchodilators most days in the previous week (i.e. answer to question #6 on ACQ-6 = 4, 5, or 6)
•4. Oxygen saturation \< 94% on room air
•5. Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months#, or \>10 pack-years of use\*
•* Can still be enrolled if ≥40 years old, smoked \<20 pack years, none within 12 months#, and demonstrate a post-bronchodilator FEV1/FVC ratio of \>0.7 or a DLCO z-score of -1.645 or greater (or the equivalent ≥ 75% of predicted) documented in prior 12 months or during run-in
•\* Smoking equivalent pack years. One pack of cigarettes a day for 1 year is equivalent to:
•* 1 cigar or pipe per day for 1 year
•* Smoked hookah or shisha =1 session per day for 1 year
+30 more criteria

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Key Dates

Start Date

October 11, 2022

Primary Completion Date

September 1, 2026

Completion Date

December 1, 2026

Last Updated

March 5, 2026

Enrollment

100

ESTIMATED participants

Conditions

Asthma

Interventions

Semaglutide Pen Injector 2.4mg weekly

DRUG

Placebo

OTHER

Contacts

Katherine Cahill, MD

CONTACT

615-936-1269 Katherine.cahill@vumc.org

Deborah Hunter

CONTACT

615-936-9123 deborah.l.hunter@vumc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

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