GLP-1 Receptor Agonist for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the impact of Semaglutide on bone health in young people with obesity. Participants will either take Semaglutide, a treatment that aids weight loss, or focus on lifestyle changes like diet and exercise. The study will monitor changes in bone health over two years through various check-ups and tests. Individuals with obesity who are starting Semaglutide treatment or managing their weight through lifestyle changes are well-suited for this trial. As a Phase 2 trial, this research measures how well Semaglutide works in an initial, smaller group, offering participants the chance to contribute to important findings.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications to join the trial. If you are taking medications like metformin, phentermine, topiramate, or certain antipsychotics, you might need to stop them if you've been on them for less than 6 months or if your dosage hasn't been stable for more than 2 months. Additionally, if you are on medications affecting bone health, like glucocorticoids, you may need a 3-month break from them before joining, if it's safe to do so.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Semaglutide is generally safe for use. It already aids in weight loss and reduces heart risks in people with diabetes. Studies have found that it can lead to significant weight loss, though some individuals might experience side effects such as nausea, diarrhea, or constipation. These side effects are usually mild and often improve over time. Importantly, studies conducted so far have not identified any major safety issues.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer a fresh approach to managing obesity in young people. The GLP-1 receptor agonist, semaglutide, stands out because it not only helps control appetite but also has been shown to improve metabolism, which can be a game-changer for young patients struggling with weight issues. Unlike traditional lifestyle management alone, which focuses on diet and exercise, semaglutide works on a hormonal level to help regulate the body's weight balance. Additionally, both treatment groups include Calcium and Vitamin D supplementation, which supports bone health, a crucial consideration for growing adolescents.
What evidence suggests that this trial's treatments could be effective for bone health in participants with obesity?
Research shows that semaglutide, a type of medication, helps manage weight by mimicking hormones that control blood sugar and appetite. Studies have found that semaglutide aids weight loss and improves heart health in people with obesity. In this trial, one group of participants will receive semaglutide along with Calcium and Vitamin D. Combined with lifestyle changes, these benefits can increase, promoting weight loss and overall health improvement. However, stopping semaglutide might lead to weight gain. This treatment has been successfully used in adults, with increasing evidence supporting its effectiveness. Another group in this trial will focus on lifestyle management overseen by their physician, along with Calcium and Vitamin D supplementation.24678
Who Is on the Research Team?
Madhusmita Misra, MD, MPH
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline visit before starting semaglutide therapy, including history, physical exams, lab work, imaging studies, and questionnaires
Treatment
Participants receive semaglutide therapy or lifestyle management, with calcium and vitamin D supplements, and attend study visits every 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including bone health markers and other assessments
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The Lifestyle Management will be overseen by the participants' physician for routine clinical care for the management of obesity while Calcium + Vitamin D will be provided by the research investigator.
The GLP-1 RA, semaglutide, will be prescribed by the participants' physician for routine clinical care for the management of obesity while the Calcium + Vitamin D will be provided by the research investigator.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
Citations
Real-world evidence on the utilization, clinical and ...
GLP-1RAs, like liraglutide, semaglutide, and tirzepatide, help manage weight by mimicking hormones that control blood sugar and appetite.
Semaglutide and Cardiovascular Outcomes in Obesity ...
Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes.
Discontinuation and Reinitiation of GLP-1 Receptor Agonists
Conclusions and Relevance In this cohort study, most patients with overweight or obesity discontinued GLP-1 RA therapy within 1 year, but those ...
A systematic review and meta-analysis of the efficacy and ...
Weight regain after discontinuation of semaglutide and tirzepatide treatment for 52 weeks was 67% and 53%, respectively. Waist circumference, ...
Efficacy of lifestyle modification combined with GLP-1 ...
Lifestyle interventions combined with GLP-1RAs may help reduce body weight and improve cardiometabolic biomarkers in adults with overweight or obesity. In light ...
Efficacy and Safety of Glucagon-Like Peptide-1 Receptor ...
Compared with placebo, tirzepatide (15 mg once weekly) resulted in weight loss of up to 17.8% (95% CI, 16.3% to 19.3%) after 72 weeks of therapy ...
Weight loss outcomes, tolerability, side effects, and risks
GLP-1RAs demonstrated significant weight loss outcomes. In clinical trials, liraglutide showed a placebo-corrected weight loss of around 5 %, semaglutide 12 %, ...
Obesity Treatment With Bariatric Surgery vs GLP-1 ...
Semaglutide and tirzepatide in particular have shown promising outcomes, showing 18% to 25% total weight loss within 68 to 88 weeks of treatment ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.