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

Plain English Summary

Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3) is a Phase 2 clinical trial sponsored by Vanderbilt University Medical Center studying Asthma. This trial tests if a weight loss medication, semaglutide, can improve asthma control in adults with obesity and persistent asthma. It is for adults aged 18 and older who have symptomatic asthma despite using inhaled steroids and have obesity. Participants will receive either semaglutide or a placebo injection weekly for 26 weeks, with regular check-ups. Standard asthma treatments like inhaled steroids and rescue inhalers are the current alternatives. The trial aims to enroll 100 participants.

Official 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

Here is what you need to know about eligibility for this trial. Adults aged 18 or older with a history of asthma. Individuals with obesity (BMI of 30 or higher, or 27 with weight-related conditions like high blood pressure or diabetes). People whose asthma is not well-controlled with current steroid inhalers and have an asthma control score of 1.5 or higher. Individuals cannot join if they have diabetes, certain lung conditions, a history of pancreatitis, or specific thyroid conditions. This trial is studying Asthma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well semaglutide improves asthma symptoms and reduces inflammation in the airways, aiming to make breathing easier for participants. The specific primary outcome measures are: The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity. (Baseline to week 12); The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity. (Baseline to week 4). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a gap in asthma treatment by investigating if a medication approved for diabetes and obesity can also help manage asthma symptoms in obese individuals, potentially offering a new Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Asthma, where improved treatment options are needed.

Investor Insight

This trial signals a potential expansion for GLP-1 receptor agonists beyond diabetes and obesity into respiratory conditions, a large and growing market, with semaglutide being a leading drug in its c Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your asthma and overall health. Participation involves weekly injections (either the study drug or placebo) and regular clinic visits for assessments over about 6 months. You will need to maintain your current asthma medications and avoid starting new weight loss treatments during the trial. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 100 participants

Interventions

• DRUG: Semaglutide Pen Injector 2.4mg weekly — Once weekly subcutaneous injection
• OTHER: Placebo — Once weekly subcutaneous injection

Primary Outcomes

• The efficacy of semaglutide on asthma control questionnaire-7 score in subjects with symptoms, persistent asthma and obesity. (Baseline to week 12)
• The impact of semaglutide once weekly on serum periostin in subjects with symptomatic, persistent asthma and obesity. (Baseline to week 4)

Secondary Outcomes

• 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)

Full Eligibility Criteria

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
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

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
   * 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

     #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.
   * 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 

Trial Locations

• Vanderbilt University Medical Center, Nashville, Tennessee, United States

Frequently Asked Questions

Related Conditions

• Asthma
• Obesity
• Type 2 Diabetes Mellitus
• Hypertension
• Dyslipidemia
• Obstructive Sleep Apnea
• Pre-diabetes
• Cardiovascular Disease
• Metabolic Syndrome
• Respiratory Tract Inflammation

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