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Glucagon-Like Peptide-1 Receptor Agonist
Semaglutide for Obesity-Related Asthma (GATA-3 Trial)
Phase 2
Recruiting
Led By Katherine Cahill, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current obstructive sleep apnea treatment
History of physician-diagnosed asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 4 and week 12
Awards & highlights
GATA-3 Trial Summary
This trial will test whether semaglutide, an FDA-approved diabetes and obesity drug, can improve asthma control in adults who are overweight and not well-controlled with inhaled steroids.
Who is the study for?
Adults with obesity-related asthma who are overweight (BMI ≥30, or ≥27 with weight-related health issues), have a history of physician-diagnosed asthma, and show symptoms despite using inhaled steroids. Participants must not be pregnant, agree to use effective birth control if applicable, and cannot have diabetes or recent significant weight loss treatments. They should also not have used certain drugs for asthma or had pancreatitis.Check my eligibility
What is being tested?
The trial is testing Semaglutide Pen Injector against a placebo to see if it can improve asthma control and reduce airway inflammation in adults with symptomatic asthma linked to obesity. It's randomized so participants won't choose which treatment they get.See study design
What are the potential side effects?
Semaglutide may cause digestive problems like nausea or constipation, increase the risk of low blood sugar levels especially when combined with other diabetes medications, potential thyroid tumors including cancer (rare), gallbladder issues such as gallstones, and possible allergic reactions.
GATA-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently being treated for obstructive sleep apnea.
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I have been diagnosed with asthma by a doctor.
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I have asthma symptoms with a score of 1.5 or higher.
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I use a medium or high dose of inhaled steroids daily for my asthma.
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I will use effective birth control during the study.
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I am considered obese with a BMI of 30 or more, or 27 with a weight-related health issue.
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I understand the study and can give my consent.
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I have high blood pressure or have been treated for it in the last year.
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My lung function improves significantly with medication or I react strongly to certain lung tests.
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I have a diagnosed heart or blood vessel disease.
GATA-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 4 and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 4 and week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Asthma
The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity.
Secondary outcome measures
Asthma
The change in exhaled nitric oxide from semaglutide to week 12.
The change in serum periostin from semaglutide to week 12.
+3 moreGATA-3 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study Drug (Semaglutide)Experimental Treatment1 Intervention
Semaglutide 2.4mg once weekly
Group II: PlaceboPlacebo Group1 Intervention
Placebo 2.4mg once weekly
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,093 Total Patients Enrolled
12 Trials studying Asthma
4,595 Patients Enrolled for Asthma
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,387 Total Patients Enrolled
58 Trials studying Asthma
11,435 Patients Enrolled for Asthma
Katherine Cahill, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
1 Trials studying Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to semaglutide in the past.I have had gallstones but haven't had my gallbladder removed.I am of childbearing age and have a negative pregnancy test.I am currently being treated for obstructive sleep apnea.I have been diagnosed with diabetes or my HbA1c level is 6.5 or higher.I have been diagnosed with asthma by a doctor.I have a chronic lung condition like COPD or cystic fibrosis.I have asthma symptoms with a score of 1.5 or higher.I have had pancreatitis before.I use a medium or high dose of inhaled steroids daily for my asthma.I have had high triglycerides or low HDL, or been treated for these in the last year.Your kidney function test shows that your kidneys are not working well.I used my asthma inhaler less than 80% of the time required.I will use effective birth control during the study.I have high blood pressure or untreated thyroid issues.I have not used any weight loss drugs or programs in the last 90 days.I have used a monoclonal antibody for asthma in the last 4 months.I had weight loss surgery over 5 years ago and my weight has been stable or increasing.You have had a bad reaction to local anesthetics like lidocaine in the past.I have been on a stable dose of metformin, or haven't used any diabetes medication except metformin in the last 90 days.I haven't had a heart attack, unstable chest pain, stroke, or moderate heart failure in the last year.I am considered obese with a BMI of 30 or more, or 27 with a weight-related health issue.I am 18 years old or older.I understand the study and can give my consent.I have not taken any steroids in the last 28 days.I have not had cancer, except for non-melanoma skin cancer that was removed, in the last 5 years.I have high blood pressure or have been treated for it in the last year.I've used my rescue inhaler more than 8 times most days last week.I or my family have a history of medullary thyroid cancer or MEN2.Your oxygen level is less than 94% when breathing normally.I have used tobacco, e-cigarettes, or smoked marijuana in the last year or for more than 10 years.You have a past history of gastroparesis.My asthma treatment has not changed in the last 8 weeks.My lung function improves significantly with medication or I react strongly to certain lung tests.I have a diagnosed heart or blood vessel disease.You have been diagnosed with pre-diabetes based on a specific blood test result from the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Study Drug (Semaglutide)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial still accept participants?
"Affirmative. According to clinicaltrials.gov, this medical experiment is actively recruiting participants; the study was first posted on September 7th 2022 and recently updated on the 9th of that same month. The research seeks approximately 100 subjects from a single site."
Answered by AI
Is the 2.4mg weekly dosage of Semaglutide Pen Injector officially sanctioned by the FDA?
"Although the efficacy of Semaglutide Pen Injector 2.4mg weekly is yet to be verified, there has been enough evidence gathered on its safety for it to receive a score of 2 out of 3."
Answered by AI
What is the key aim of this trial?
"This clinical trial will examine the impacts of semaglutide administered weekly over a Baseline to week 12 time frame on serum periostin in subjects with symptomatic, persistent asthma and obesity. Secondary objectives include evaluating weight loss from baseline at week 24, establishing changes in exhaled nitric oxide levels between weeks 4 and 12, and measuring efficacy as indicated by ACQ-6 scores (0-6; lower is better) after twelve weeks."
Answered by AI
How many participants are being tracked in this research study?
"Affirmative. Records on clinicaltrials.gov demonstrate that, as of 9/9/2022, this clinical research is actively seeking participants to participate at one site with a goal of 100 enrollees. The trial was initially posted the 7th September 2022."
Answered by AI
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