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Semaglutide for Childhood Obesity (STEP Young Trial)

Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 0 to week 111
Awards & highlights

STEP Young Trial Summary

This trial will investigate how well semaglutide helps children and teenagers lose weight. It involves taking a medication and talks about healthy food choices, physical activity and weight loss.

Who is the study for?
This trial is for children and teenagers aged 6-17 with obesity who have tried to lose weight through a structured program without success. They must weigh over 45 kg, have a BMI in the highest percentiles, and may also have certain weight-related health issues. Parents or guardians must consent, and kids give assent.Check my eligibility
What is being tested?
The study tests Semaglutide's effectiveness in aiding weight loss compared to a placebo. Participants will receive weekly injections for about 2.5 years while also engaging in discussions on healthy lifestyle choices with study staff.See study design
What are the potential side effects?
While not specified here, common side effects of Semaglutide can include nausea, vomiting, diarrhea, abdominal pain, and constipation. It's important to monitor any adverse reactions throughout the trial.

STEP Young Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 0 to week 111
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 0 to week 111 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Group Kids: Change in body mass index (BMI)
Secondary outcome measures
Group Kids and Group Teens: Change in BMI
Group Kids and Group Teens: Change in BMI SDS
Group Kids and Group Teens: Change in BMI Standard deviation score (SDS)
+33 more

STEP Young Trial Design

2Treatment groups
Experimental Treatment
Group I: Group TeensExperimental Treatment2 Interventions
Participants in the age group 12 to < 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
Group II: Group KidsExperimental Treatment2 Interventions
Participants in the age group 6 to less than (<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,858 Total Patients Enrolled
141 Trials studying Obesity
131,828 Patients Enrolled for Obesity
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,796 Total Patients Enrolled
3 Trials studying Obesity
425 Patients Enrolled for Obesity

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05726227 — Phase 3
Obesity Research Study Groups: Group Kids, Group Teens
Obesity Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05726227 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05726227 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study include participants aged 18 and above?

"This experiment is searching for individuals aged between 6 and 18. There are 194 trials involving minors, as well as 591 studies catering to those above 65 years of age."

Answered by AI

What potential hazards can be associated with Group Kids?

"The safety of Group Kids scored a 3 on our Power rating scale, indicative of the accumulated clinical data verifying efficacy and multiple rounds validating its security."

Answered by AI

Are there any open opportunities available to participate in this research?

"This research endeavour, which was first posted on July 7th 2023 and last amended on February 20th 2023, is not actively recruiting anymore. However, 945 other studies are currently in need of volunteers."

Answered by AI

In what locations has this experimentation been implemented?

"There are presently 4 locations hosting this study: Minneapolis, Fargo and Pittsburgh being the primary ones. To reduce transportation costs, it is recommended that prospective participants select a clinic as close to them as possible."

Answered by AI

Am I eligible to be a part of this trial?

"This trial is searching for 210 minors aged 6-18 with obesity. Crucially, they must meet the following criteria: Informed consent by parent or legal representative of participant and child assent obtained prior to any study activities; Age at time of signing informed consent (Group Kids: 6 - <12 years, Group Teens 12 -< 18 years); Body mass index (BMI) >= 95th percentile for both groups or 85th percentile + 1 weight-related comorbidity; History of least one fruitless attempt to lose sufficient bodyweight through structured lifestyle modification program lasting 3 months minimum; Bodyweight >45 kg at screening"

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight
2023. "A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05726227.
All > Fargo > Meridian
~135 spots leftby Nov 2025
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