Semaglutide for Obesity-Related Asthma
(GATA-3 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Vanderbilt University Medical Center
Must be taking: Inhaled corticosteroids
Must not be taking: Antidiabetic agents, Glucocorticoids
Disqualifiers: Diabetes, Smoking, Pregnancy, others
Prior Safety Data
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if semaglutide, a diabetes and weight loss drug, can help overweight adults with asthma who still have symptoms despite using inhaled steroids. The medication may reduce lung inflammation and improve breathing. Semaglutide is a drug used for diabetes and weight loss, and it has shown potential in delaying or preventing diabetes onset in individuals with prediabetes and obesity.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain medications like systemic glucocorticoids, some antidiabetic agents, or monoclonal antibodies for asthma treatment before joining. Metformin is allowed if the dose is stable.
What data supports the effectiveness of the drug semaglutide for obesity-related asthma?
Semaglutide has been shown to help with significant weight loss in people with obesity, which can improve conditions related to obesity, like type 2 diabetes. This weight loss effect might also help with obesity-related asthma, as losing weight can often improve asthma symptoms.
12345Is semaglutide safe for humans?
Semaglutide has been shown to be generally safe in humans, with common side effects being mild-to-moderate gastrointestinal issues that usually resolve on their own. It has been approved for use in managing type 2 diabetes and weight management, with a safety profile consistent with other similar medications.
16789How is the drug semaglutide unique for treating obesity-related asthma?
Semaglutide is unique because it is a once-weekly injection that not only helps with weight loss but also improves cardiometabolic health, which can be beneficial for obesity-related asthma. Unlike other treatments, it offers significant and sustained weight loss, which can help reduce asthma symptoms linked to obesity.
310111213Eligibility Criteria
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.Inclusion Criteria
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 asthma by a doctor.
+12 more
Exclusion Criteria
You have had a bad reaction to semaglutide in the past.
Inability or unwillingness of a subject to give written informed consent or comply with the study protocol
I have had gallstones but haven't had my gallbladder removed.
+24 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
Treatment
Participants receive semaglutide or placebo once weekly for 24 weeks
24 weeks
Weekly visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
Participant Groups
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.
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
Semaglutide is already approved in European Union, United States, Canada, Japan, United States, United States for the following indications:
🇪🇺 Approved in European Union as Ozempic for:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
🇺🇸 Approved in United States as Ozempic for:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
🇨🇦 Approved in Canada as Ozempic for:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
🇯🇵 Approved in Japan as Ozempic for:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
🇺🇸 Approved in United States as Wegovy for:
- Obesity
🇺🇸 Approved in United States as Rybelsus for:
- Type 2 diabetes
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]Semaglutide (Ozempic®) is a new once-weekly agonist of glucagon-like peptide-1 receptors (GLP-1 AR) indicated in the treatment of type 2 diabetes (T2D). Phase III clinical trials of the SUSTAIN programme demonstrated both the efficacy and safety of semaglutide in patients with T2D treated by diet and exercise, oral antidiabetic agents or even insulin. Direct and indirect comparative clinical trials showed that semaglutide (subcutaneous 0.5 or 1.0 mg once weekly) exerts a better glucose-lowering activity and a greater weight loss than other GLP-1 AR. Presented as prefilled pens for subcutaneous injection, semaglutide is currently reimbursed in Belgium after failure of antidiabetic therapy including metformin (HbA1c superior to 7,5 % or 58 mmol/mol) in T2D patients with body mass index ? 30 kg/m².
Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. [2023]To explore the effects of oral semaglutide on glycaemic parameters, body weight, and satisfaction in the first recipient patients with type 2 diabetes mellitus in Slovenia, in a real-world clinical practice setting.
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]The treatment of obesity can no longer be reduced to a simplistic view of weight loss. Metabolic adaptation leads to systematic weight regain following weight-loss efforts, and new obesity treatments should therefore aim to induce long-standing double-digit weight loss, and thus improve and even reverse obesity-associated comorbidities such as type 2 diabetes. Until now, only metabolic surgery has been able to achieve such a goal, but this invasive procedure cannot be offered on a large scale. Among the alternatives, lifestyle interventions and drug therapies have often been disappointing. The recent availability of once-weekly subcutaneous 2.4 mg semaglutide (a glucagon-like peptide-1 receptor agonist; Wegovy™ Novo Nordisk A/S, Bagsværd, Denmark) has changed the scene, and semaglutide is considered a 'game changer' in the treatment of obesity. The results from the phase III STEP (Semaglutide treatment effect in people with obesity) clinical programme have shown that semaglutide provides clinically meaningful and sustained weight loss in ranges much higher than those achieved with previously available pharmacotherapies. These results led to the approval of semaglutide by regulatory authorities as an adjunct to a reduced-calorie diet and increased physical activity in people with obesity or overweight, with at least one weight-related comorbidity. With data from phase II and III clinical trials showing that newer drugs (i.e. the glucagon-like peptide-1 and gastric inhibitory polypeptide dual receptor agonist tirzepatide and the amylin agonist cagrilintide, either alone or combined) produce a greater sustained weight loss than semaglutide, an upstream 'weight-centric' strategy has emerged as a new standard for the treatment of type 2 diabetes.
Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]We assessed the efficacy and safety of the oral glucagon-like peptide-1 analogue, semaglutide 50 mg, taken once per day versus placebo for the treatment of overweight or obesity in adults without type 2 diabetes.
Clinical Insight on Semaglutide for Chronic Weight Management in Adults: Patient Selection and Special Considerations. [2023]Losses of 5-10% or more of initial body weight are associated with improvements in obesity-related comorbidities. However, attaining and sustaining this level of weight loss is challenging. The novel anti-obesity medication semaglutide 2.4 mg injected subcutaneously once weekly as an adjunct to a reduced-calorie diet and physical activity helps patients achieve average losses of 9.6-17.4% of initial body weight at week 68, as well as improvements in cardiometabolic and psychosocial indices. Despite these average benefits, prescribers should carefully assess the suitability of patients for this medication. In this paper, we discuss considerations for the selection of individuals who are candidates for semaglutide and special considerations related to the use of this medication. These include its efficacy and safety, as well as its contraindications, potential adverse effects, management of comorbidities and drug interactions, insurance coverage and cost, and patient preferences.
Efficacy and safety of once-weekly semaglutide in adults with overweight or obesity: a meta-analysis. [2022]This meta-analysis aimed to assess the efficacy and safety of once-weekly semaglutide among adults with overweight or obesity.
Efficacy and safety of semaglutide for weight management: evidence from the STEP program. [2023]Obesity is a global health challenge. It is a multifactorial, complex, and progressive disease associated with various health complications and increased mortality. Lifestyle modifications are central to weight management but may be insufficient to maintain clinically meaningful weight loss. Pharmacotherapies are recommended as an adjunct to lifestyle interventions to induce and sustain clinically meaningful weight loss and reduce the risk of comorbidities in appropriate patients. Glucagon-like peptide-1 is an incretin metabolic hormone responsible for a range of physiological effects, including glucose and appetite regulation. Several glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been approved for the treatment of type 2 diabetes since 2005 including exenatide (short- and extended-release), lixisenatide, liraglutide, dulaglutide, albiglutide, and semaglutide. Of these, semaglutide (subcutaneous) and liraglutide are currently US Food and Drug Administration (FDA)-approved for chronic weight management in patients with or without diabetes. The phase 3 Semaglutide Treatment Effect in People with obesity (STEP) program was designed to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with overweight or obesity. Following the submission of the results of the STEP 1-4 trials, the FDA approved once-weekly subcutaneous semaglutide 2.4 mg for chronic weight management in people with overweight or obesity in April 2021. Data from the program demonstrated that semaglutide (2.4 mg once weekly) achieved significant and sustained weight loss, together with improvements in cardiometabolic risk factors compared with placebo, and was generally well tolerated, with a safety profile consistent with other GLP-1RAs. The most common adverse events reported in STEP 1-5 were gastrointestinal events, which were transient, mild-to-moderate in severity, and typically resolved without permanent treatment discontinuation. This article reviews the data from STEP 1-5 and highlights clinically relevant findings for primary care providers.
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]Oral semaglutide (Rybelsus®) is a co-formulation of semaglutide, a glucagon-like peptide-1 (GLP-1 RA) receptor agonist, with an absorption enhancer, sodium N- (8- [2- hydroxybenzoyl] amino) caprylate (SNAC), which facilitates the absorption of semaglutide across the gastric epithelium in a concentration dependent manner. The safety and efficacy of oral semaglutide were assessed in the PIONEER clinical trial programme, which included 9543 patients with type 2 diabetes (T2DM). Across a range of different T2DM patients receiving different background medications, oral semaglutide provides more effective glycaemic control than common oral glucose-lowering therapies, associated with a clinically relevant reduction in body weight, including in patients with more advanced T2DM on insulin treatment. The tolerability profile for oral semaglutide was consistent with the other GLP-1 RAs. Cardiovascular (CV) safety of oral semaglutide was noninferior to placebo in CV high-risk patients. Available in three doses (3, 7 and 14 mg) to be gradually increased, Rybelsus® is currently reimbursed in Belgium after failure of antidiabetic treatment (including metformin; HbA1C superior to 7.5 % or 58 mmol/mol) in T2DM patients with a body mass index ? 30 kg/m².
Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]Semaglutide is an oral glucagon-like peptide receptor agonist approved in 2019 by the U.S. Food and Drug Administration. It is marketed under the brand name Rybelsus and was approved to be used in conjunction with lifestyle modifications to treat individuals with type 2 diabetes. It is the first in its drug class to be administered in a once-daily oral form. Through its actions on glucose control and body weight, this once-daily oral medication could contribute to better glycemic control and healthier lives for many women with type 2 diabetes.
Cardiometabolic risk factors efficacy of semaglutide in the STEP program. [2023]People with overweight or obesity often suffer from associated cardiometabolic diseases and comorbidities. Current therapies for obesity include lifestyle intervention, bariatric surgery, and pharmacotherapy. The magnitude of weight loss achieved with these therapies can determine the level of improvement in various comorbidities. Once-weekly subcutaneous semaglutide 2.4 mg is a glucagon-like peptide-1 receptor agonist recently approved by the US Food and Drug Administration for the treatment of obesity. This article reviews data from the global phase 3 Semaglutide Treatment Effect in People with obesity (STEP) program, comparing the efficacy of once-weekly subcutaneous semaglutide 2.4 mg versus placebo for weight loss and improvements in cardiometabolic parameters across the STEP 1 to 5 trials. In STEP 1 to 3 and STEP 5, semaglutide led to greater reductions from baseline versus placebo in body weight, waist circumference, body mass index, systolic blood pressure (SBP), and diastolic blood pressure, as well as positive changes in glycated hemoglobin (HbA1c), C-reactive protein, and lipid levels. In STEP 4, all participants had a 20-week run-in period on semaglutide before either continuing on semaglutide or switching to placebo at week 20 in a 2:1 ratio for 48 weeks. At week 68, continued semaglutide led to further reductions from week 20 in HbA1c, improvements in lipid profile, and stabilization of SBP. Overall, across the STEP trials, treatment with semaglutide 2.4 mg versus placebo improved cardiometabolic risk factors associated with obesity, illustrating an effective treatment option for people with overweight (and associated comorbidities) or obesity.
Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]Cardiovascular disease is the most common cause of morbidity and mortality worldwide, and the risk is heightened in the presence of obesity. We review semaglutide, a drug recently approved for chronic weight management in adults with obesity or who are overweight.
Semaglutide-eye-catching results. [2023]Semaglutide is a glucagon-like peptide-1 receptor agonist used either orally every day or subcutaneously once a week for the treatment of type 2 diabetes mellitus and, more recently, at higher doses, for the treatment of obesity. Both diseases are reaching epidemic proportions and often coexist, posing patients with a high risk for cardiovascular disease and death. Therefore, an agent such as semaglutide, which offers clinically significant weight loss and cardiovascular benefits, is essential and will be increasingly used in high-risk patients. However, during the SUSTAIN clinical trial program (Semaglutide Unabated Sustainability in treat-ment of type 2 diabetes), a safety issue concerning the progression and worsening of diabetic retinopathy emerged. The existing explanation so far mainly supports the role of the magnitude and speed of HbA1c reduction, a phenomenon also associated with insulin treatment and bariatric surgery. Whether and to which extent the effect is direct is still a matter of debate and an intriguing topic to investigate for suitable preventative and rehabilitative purposes. In this minireview, we will summarize the available data and suggest guidelines for a comprehensive semaglutide clinical utilization until new evidence becomes available.
Semaglutide for the treatment of obesity. [2023]Semaglutide is a glucagon-like peptide-1 receptor agonist that was recently approved by the US Food and Drug Administration for chronic weight management. This paper reviews data on the mechanism of action, weight-loss and cardiometabolic efficacy, and safety of semaglutide 2.4 mg/week for obesity. Semaglutide has demonstrated the largest weight loss of any obesity medication to date with reductions of approximately 15% of initial weight at 68 weeks, accompanied by improvements in cardiovascular risks factors and physical functioning. The approval of this medication provides patients with greater options for weight management.