Semaglutide for Childhood Obesity

(GLOW Trial)

DN
Overseen ByDawn Nederhoff
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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.678910

Who Is on the Research Team?

AK

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

My BMI is at or above the 95th percentile for my age and sex.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying doses of Health Behavior and Lifestyle Treatment (HBLT) for 52 weeks

52 weeks
Weekly group classes and individual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

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

Group I: Medium Dose HBLTExperimental Treatment1 Intervention
Group II: Low Dose HBLTExperimental Treatment1 Intervention
Group III: High Dose HBLTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+

Novo Nordisk A/S

Industry Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

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 profile image

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. ...

Semaglutide 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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safetydata.fra.dot.gov

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FRA-Homepage

This new page contains links to the new FRA safety data page, released in December 2024, which includes reports, full datasets, and PDF reports for train ...

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