Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic … (NCT05254314) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)
United States100 participantsStarted 2022-10-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. . 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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity.
Timeframe: Baseline to week 12
2
The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.
. 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
Exclusion criteria
. 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\*
. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period
. Pharmaceutical weight loss treatment for \>7 days in the prior 90 days at enrollment
. 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.