Semaglutide Nasal Spray for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new nasal spray form of semaglutide, a medication designed to help people with obesity lose weight. Researchers aim to determine the safety and tolerability of the nasal spray and compare it to a placebo (a substance with no active medication) and a standard injection. Participants who are overweight or have obesity, with a relatively stable weight for the past three months, might be suitable candidates. However, this study does not include individuals with diabetes or certain other medical conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new form of medication.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that affect body weight, such as anti-obesity drugs, glucagon-like peptide-1 (GLP-1) receptor agonists, and some antidepressants and antipsychotics, at least 3 months before screening. If you're on any of these, you may need to stop them to participate.
Is there any evidence suggesting that Semaglutide Nasal Spray is likely to be safe for humans?
Research has shown that semaglutide is generally well-tolerated for weight management. In one study, individuals without type 2 diabetes who used semaglutide lost about 11.85% of their starting weight safely and effectively. Additionally, semaglutide has been linked to a lower risk of heart-related hospitalizations and deaths.
While semaglutide is usually safe, reports of overdoses highlight the importance of following dosage instructions carefully. For those considering joining a trial, the safety data for semaglutide, including its use as a nasal spray, appears promising based on past studies.12345Why do researchers think this study treatment might be promising?
Unlike the standard obesity treatments that often involve oral medications or injections, semaglutide nasal spray offers a unique delivery method. This nasal spray could provide a more convenient and potentially faster-acting option, as it bypasses the digestive system and enters the bloodstream directly through the nasal passages. Researchers are excited about semaglutide because it is a GLP-1 receptor agonist, which is known to help regulate appetite and enhance weight loss, but in this new easy-to-use form, it may improve patient adherence and outcomes. Additionally, the trial includes a comparison with semaglutide injections, offering insights into the efficacy and preference between different delivery methods.
What evidence suggests that Semaglutide Nasal Spray might be an effective treatment for obesity?
Research has shown that semaglutide can aid in weight loss. One study found that participants taking 2.4 mg of semaglutide lost about 15.7 kg more than those not using any weight-loss medication. Another study demonstrated that a higher dose of semaglutide resulted in an average weight loss of 20.7%, outperforming lower doses and a placebo. This trial will assess the effectiveness of semaglutide administered as a nasal spray, with some participants receiving only the semaglutide nasal spray, while others will receive it combined with a placebo. Additionally, semaglutide may improve heart health while aiding weight loss in overweight or obese adults. Overall, semaglutide appears to be a promising option for managing weight in individuals with obesity.15678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 who are overweight or mildly obese (BMI 27–35), have had stable weight recently, and do not have diabetes, major health issues, recent nasal problems, or a history of certain cancers. Participants must use contraception and cannot be pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single-dose administration of Semaglutide Nasal Spray or placebo
Follow-up
Participants are monitored for safety, tolerability, and pharmacokinetics after administration
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide Nasal Spray
Trial Overview
The study compares the safety and how the body processes semaglutide given as a nasal spray versus an injection in overweight or obese adults. Some participants will receive placebo instead of active medication. Treatments are assigned randomly.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai World Leader Pharmaceutical Co., Ltd.
Lead Sponsor
Citations
Semaglutide 2.4 mg Clinical Outcomes in Patients with ...
Compared with patients who did not take obesity medication, patients taking semaglutide 2.4 mg lost 15.7 kg (34.6 pounds) more on average. In ...
A Clinical Study of Semaglutide Nasal Spray in Overweight ...
The specific aim of this study is to examine the Safety, Tolerability and Pharmacokinetic of Semaglutide Nasal Spray compared with placebo and ...
Effectiveness and safety of semaglutide in overweight/obese ...
Semaglutide can effectively lose weight in overweight or obese adults with or without diabetes, potentially providing cardiovascular benefits.
4.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/step-up-trial-semaglutide-superior-weight-lossSTEP UP Trial Shows Semaglutide 7.2 mg Achieves ...
Semaglutide 7.2 mg significantly outperformed semaglutide 2.4 mg and placebo with a 20.7% average reduction in weight and a comparable safety and tolerability ...
5.
novomedlink.com
novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/chronic-weight-management.htmlChronic Weight Management Trial Results | Wegovy ...
Efficacy estimand: ~17% mean weight loss · Randomized clinical trials (RCTs) · Real-world observational studies ...
Semaglutide effects on safety and cardiovascular ...
Conclusion: The use of semaglutide reduced 76% in hospitalization due to HF, 17% deaths due to cardiovascular causes, 21% deaths due to any ...
7.
novonordisk-trials.com
novonordisk-trials.com/content/dam/nntrials/global/en/studies/data/4379%20lay%20summary.pdfResearch study investigating how well semaglutide works ...
The researchers wanted to find out if semaglutide can help people living with overweight or obesity to lose body weight when used together with exercise and low ...
Efficacy and Safety of Semaglutide for Weight Loss in ...
Among individuals with obesity without type 2 diabetes, subcutaneous semaglutide is effective for weight loss with an 11.85% reduction from baseline compared ...
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