Semaglutide for Childhood Obesity
(GLOW Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the medication semaglutide to determine its effectiveness in helping teens manage obesity. Researchers are examining whether varying levels of health behavior and lifestyle treatments (HBLT), such as group classes and goal-setting sessions, should accompany the medication. The study aims to identify whether a high, medium, or low dose of these lifestyle treatments is most effective. Teens aged 12 to 17 with a BMI in the 95th percentile or higher, who can participate in virtual sessions, may be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.
What is the safety track record for Semaglutide?
Research has shown that semaglutide is generally safe for people. The FDA has approved semaglutide for treating type 2 diabetes and obesity in adults, indicating a well-understood safety profile. In studies with adults, most participants tolerated semaglutide well. Common side effects included mild symptoms like nausea and diarrhea. Serious side effects were rare, but monitoring for them remains important. Since this study is in a later phase, semaglutide has demonstrated considerable safety up to this point.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about semaglutide for treating childhood obesity because it offers a new approach compared to standard treatments like lifestyle changes, diet, and exercise alone. Semaglutide is unique because it mimics a hormone called GLP-1 that helps regulate appetite and insulin levels, potentially leading to more effective weight management in children. Unlike other treatments that primarily focus on behavior modification, semaglutide directly influences the body’s biological processes to help reduce hunger and control weight. This could make it a promising option for children struggling with obesity who need more than traditional methods to achieve and maintain a healthy weight.
What evidence suggests that this trial's treatments could be effective for childhood obesity?
Research has shown that semaglutide effectively helps teenagers lose weight. In one study, participants taking semaglutide lost an average of 9.7 kg (about 21 pounds) over a year, equating to about 8.9% of their total body weight. Another study found that nearly 37% of teens using semaglutide lost more than 20% of their weight, with an average loss of about 15 kg. Additionally, teens on semaglutide saw their BMI (body mass index) drop by an average of 16.1% during the study. These results suggest that semaglutide can significantly aid teens with obesity in losing weight.
In this trial, researchers will randomize participants to receive different doses of HBLT (High, Medium, or Low) alongside semaglutide to evaluate the combined effectiveness of these interventions.678910Who Is on the Research Team?
Aaron Kelly, PhD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adolescents with obesity, specifically those whose BMI is at or above the 95th percentile for their age and sex. Participants should be otherwise healthy enough to join as determined by the study team.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive varying doses of Health Behavior and Lifestyle Treatment (HBLT) for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
Trial Overview
The study tests semaglutide (a medication that helps with weight loss) combined with either intensive or low-intensity lifestyle and health behavior programs, to see which approach works best for teens with obesity.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Individuals in this group will be randomized to receive medium dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with condensed information, skill building and strategies in addition to individual goal setting sessions.
Individuals in this group will be randomized to receive low dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with a brief overview of topics in addition to individual goal setting sessions.
Individuals in this group will be randomized to receive high dose HBLT during the first 52 weeks of the study. The HBLT will consist of group classes with detailed education, skill building and strategies on specific topics in addition to individual goal setting sessions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Novo Nordisk A/S
Industry Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
Citations
Latest Obesity Drug Not Cost-Effective for Adolescents
Wegovy (semaglutide) produces the greatest weight loss in teenagers, the trendy obesity drug is not cost-effective at its current price. 13 ...
Efficacy, Safety and Pharmacokinetics of Semaglutide 1.7 mg ...
semaglutide provides comparable exposure, tolerability and meaningful BMI reduction in adolescents versus adults and versus 2.4 mg.
Semaglutide for Childhood Obesity (STEP Young Trial)
One study found that kids who took semaglutide lost an average of 9.7 kg (about 21 pounds) over a year, which is around 8.9% of their total body weight.
Pharmacological Management of Obesity in Children and ...
outcomes of semaglutide 2.4mg. Over a period of 68 weeks, semaglutide showed BMI reduction by 16.7%, equivalent to a BMI SDS reduction of 1.0. reduction of 12. ...
5.
publications.aap.org
publications.aap.org/aapgrandrounds/article/49/4/40/190862/Semaglutide-for-Adolescents-With-ObesitySemaglutide for Adolescents With Obesity
Almost 37% of participants on semaglutide experienced a >20% reduction in body weight over the study period (average weight loss of ~15 kg).
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