RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-11

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05254314

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 stable asthma controller regimen for the prior 8 weeks 8. 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 9. Female subjects of childbearing potential must have a negative pregnancy test upon study entry 10. 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	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 * 1 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 * 1 use of inhaled marijuana per day for 1 year * 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. * Any electronic (e)-device included: e-cigarette e-cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods, etc. * Any form of inhaled marijuana, including smoking marijuana leaves or inhaling THC via e-cigarette or device 6. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period 7. Pharmaceutical weight loss treatment for \>7 days in the prior 90 days at enrollment 8. Previous surgical weight loss treatment. Can still be enrolled if surgery \> 5 years ago and evidence of stable or increasing weight in the prior 3-12 months. 9. Personal history of pancreatitis as determined by history 10. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2 11. Personal history of gallstone disease without previous cholecystectomy 12. Personal history of gastroparesis 13. Personal history of hypersensitivity to semaglutide 14. Personal history of hypersensitivity to local amide type (ex. Lidocaine) anesthetics 15. Use of antidiabetic agent, other than metformin, including GLP-1R agonist in the previous 90 days. Metformin is allowed provided the dose has been stable in the 90 days prior to screening and will remain stable for the duration of the trial. 16. Use of systemic glucocorticoids in the past 28 days 17. Use of monoclonal antibody for the treatment of asthma in the past 120 days 18. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history 19. Patient report and confirmed by review of historical diagnostic testing by study physician of other physician-diagnosed chronic respiratory diseases: COPD, cystic fibrosis, pulmonary hypertension, interstitial lung disease, sarcoidosis, bronchiectasis 20. History of physician-diagnosed immune deficiency. 21. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years. 22. Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism 23. Current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements. 24. Use of investigational drugs within 20 weeks of participation, other than vaccines and/or treatments for SARS-CoV-2 authorized for emergency use 25. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 26. Screening creatinine elevation with EGFR\<30 ml/min/1.73 m2 collected at visit 1a 27. Compliance to baseline asthma inhaler therapy of \<80% during run-in, at the time of randomization.

Inclusion Criteria

Exclusion 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 stable asthma controller regimen for the prior 8 weeks
8. 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
9. Female subjects of childbearing potential must have a negative pregnancy test upon study entry
10. 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

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
* 1 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
* 1 use of inhaled marijuana per day for 1 year
* 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.
* Any electronic (e)-device included: e-cigarette e-cig, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods, etc.
* Any form of inhaled marijuana, including smoking marijuana leaves or inhaling THC via e-cigarette or device
6. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period
7. Pharmaceutical weight loss treatment for \>7 days in the prior 90 days at enrollment
8. Previous surgical weight loss treatment. Can still be enrolled if surgery \> 5 years ago and evidence of stable or increasing weight in the prior 3-12 months.
9. Personal history of pancreatitis as determined by history
10. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2
11. Personal history of gallstone disease without previous cholecystectomy
12. Personal history of gastroparesis
13. Personal history of hypersensitivity to semaglutide
14. Personal history of hypersensitivity to local amide type (ex. Lidocaine) anesthetics
15. Use of antidiabetic agent, other than metformin, including GLP-1R agonist in the previous 90 days. Metformin is allowed provided the dose has been stable in the 90 days prior to screening and will remain stable for the duration of the trial.
16. Use of systemic glucocorticoids in the past 28 days
17. Use of monoclonal antibody for the treatment of asthma in the past 120 days
18. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history
19. Patient report and confirmed by review of historical diagnostic testing by study physician of other physician-diagnosed chronic respiratory diseases: COPD, cystic fibrosis, pulmonary hypertension, interstitial lung disease, sarcoidosis, bronchiectasis
20. History of physician-diagnosed immune deficiency.
21. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years.
22. Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism
23. Current, diagnosed or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
24. Use of investigational drugs within 20 weeks of participation, other than vaccines and/or treatments for SARS-CoV-2 authorized for emergency use
25. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
26. Screening creatinine elevation with EGFR\<30 ml/min/1.73 m2 collected at visit 1a
27. Compliance to baseline asthma inhaler therapy of \<80% during run-in, at the time of randomization.

Contacts and Locations

Study Contact

Katherine Cahill, MD

CONTACT

615-936-1269

Katherine.cahill@vumc.org

Deborah Hunter

CONTACT

615-936-9123

deborah.l.hunter@vumc.org

Principal Investigator

Katherine Cahill, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Katherine Cahill, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-11

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-10-11

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Asthma