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

NCT05254314 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: DAIT-U01-VAN-003U01AI155299
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Obesity; Semaglutide; Glucagon-like peptide-1 receptor agonist; www.tnasthmaobesitystudy.com

Outcome Measures

Primary Outcomes (2)

• The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity.

  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.

  Baseline to week 12

• The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.

  The primary mechanistic outcome is the difference between the treatment and placebo groups in change from baseline in serum periostin at week 4.

  Baseline to week 4

Secondary Outcomes (6)

• The impact of semaglutide on weight loss over time.

  Baseline to week 24

• The efficacy of semaglutide once weekly on asthma control questionnaire-6 score in subjects with symptomatic, persistent asthma and obesity

  Baseline to week 12

• The maximal dose of semaglutide tolerated in persistent asthma with obesity.

  Baseline to week 24

• Incidence of treatment-emergent adverse events from semaglutide in persistent asthma with obesity.

  Baseline to week 26

• The change in exhaled nitric oxide from semaglutide to week 12.

  Baseline to week 4 and week 12

Study Arms (2)

Study Drug (Semaglutide)

EXPERIMENTAL

Semaglutide 2.4mg once weekly

Drug: Semaglutide Pen Injector 2.4mg weekly

Placebo

PLACEBO COMPARATOR

Placebo 2.4mg once weekly

Other: Placebo

Interventions

Semaglutide Pen Injector 2.4mg weekly DRUG

Once weekly subcutaneous injection

Also known as: Wegovy

Study Drug (Semaglutide)

Placebo OTHER

Once weekly subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able to understand and provide informed consent.
• Males and females age 18 or older
• 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
• History of physician-diagnosed asthma
• Persistent Asthma as determined by the requirement of at least medium-dose daily inhaled corticosteroid or more
• Symptomatic asthma with an ACQ-6 score \>=1.5 at enrollment and at the time of randomization
• Patient report of stable asthma controller regimen for the prior 8 weeks
• Evidence of bronchodilator responsiveness (\>=12% and at least 200 mL increase in FEV1) or airway hyperresponsiveness with a Methacholine PC20 \<=16 mg/mL or PD20 \<=400 mcg in the prior year
• Female subjects of childbearing potential must have a negative pregnancy test upon study entry
• Female subjects of childbearing potential must agree to use a highly effective birth control method (e.g. hormonal, surgical or abstinence) for the duration of the study

You may not qualify if:

• At enrollment:
• Inability or unwillingness of a subject to give written informed consent or comply with the study protocol
• Diagnosis of type I or type II diabetes mellitus (DM) or HbA1c ≥6.5 on screening labs
• 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)
• Oxygen saturation \< 94% on room air
• 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:
• cigar or pipe per day for 1 year
• Smoked hookah or shisha =1 session per day for 1 year
• Vaped e-cigarettes =0.5 mLs e-liquid per day for 1 year, or =1 cartridge/tank/pod per day for 1 year
• use of inhaled marijuana per day for 1 year
• #Use of any inhalant \>1 time weekly in the past year is considered use within 12 months.
• Active smoking of conventional tobacco, inhaling of marijuana or other drugs, or vaping of e-cigarettes or vape pods \>1 time per week in the past year.
• Any form of tobacco qualifies, such as: 1 cigarette, 1 hookah or shisha sessions, 1 cigar, 1 pipe, etc.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Related Publications (1)

• Tomasello A, Bacharier LB, Becker PM, Dempsey C, Wu P, Peebles RS, Niswender K, Dupont WD, Bernard G, Cahill KN. Untangling obese asthma: Design of proof-of-concept study of semaglutide in poorly controlled asthma. J Allergy Clin Immunol Glob. 2025 Dec 17;5(2):100627. doi: 10.1016/j.jacig.2025.100627. eCollection 2026 Mar.

  PMID: 41567689 DERIVED

Related Links

• Study Approved Website

MeSH Terms

Conditions

Asthma; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine Cahill, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Cahill, MD

CONTACT

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

Deborah Hunter

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, placebo-controlled, single-center, proof-of-concept study with 2 treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Asthma Clinical Research

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: October 11, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)