Semaglutide for Childhood Obesity

(STEP Young Trial)

Not currently recruiting at 115 trial locations

Overseen By Novo Nordisk

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must not be taking: Obesity medications

Disqualifiers: Type 1 diabetes, Endocrine obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the medication semaglutide might help children and teenagers lose weight. Participants will receive either semaglutide or a placebo ("dummy" medicine) and will also receive support for healthy eating and exercise. The goal is to determine if semaglutide makes a significant difference compared to the placebo. Children and teens who have been unable to lose weight despite diet and exercise programs and have a body mass index (BMI) at or above the 95th percentile might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken any medication for obesity or weight management in the 90 days before the study.

Is there any evidence suggesting that semaglutide is likely to be safe for children and teenagers?

Research shows that semaglutide appears safe for children and teenagers, although some side effects can occur. Earlier studies with teens reported common side effects such as mild stomach issues, including nausea and diarrhea. One study mentioned a case of gallstones, and a few participants stopped treatment due to side effects.

Semaglutide has been used in adults to manage type 2 diabetes and weight, offering some reassurance about its safety. However, individual reactions can vary, so careful monitoring is necessary. Participants in a trial will be closely monitored by the study team for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for childhood obesity?

Researchers are excited about semaglutide for childhood obesity because it offers a new approach by mimicking a hormone called GLP-1, which helps regulate appetite and food intake. Unlike traditional weight management methods like lifestyle changes and medications such as orlistat, semaglutide is administered as a once-weekly injection, making it potentially more convenient and consistent for young patients. Moreover, semaglutide has shown promise in adult obesity trials, indicating it might be highly effective in reducing weight, which makes it a promising candidate for younger populations struggling with obesity.

What evidence suggests that semaglutide might be an effective treatment for childhood obesity?

In this trial, participants will receive either semaglutide or a placebo as part of their treatment. Research has shown that semaglutide helps children and teenagers with obesity lose weight. 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. Another study showed that teenagers experienced significant reductions in their BMI (a measure of body fat based on height and weight) with semaglutide. This medication is already approved for weight management in adults, suggesting it could be promising for younger people too. Overall, the evidence supports semaglutide as a strong option for managing obesity in children and teens. ^{2 3 4 6 7}

Who Is on the Research Team?

Clinical Transparency dept. 2834

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Parents or LAR of the child must sign and date the Informed Consent Form

Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent obtained before any study-related activities

Child must sign and date the Child Assent Form or provide oral assent

Exclusion Criteria

I haven't taken obesity or weight management drugs in the last 90 days.

I have had or plan to have weight loss surgery or use a device, except in specific cases.

Participants with endocrine, hypothalamic, or syndromic obesity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once weekly subcutaneous injection of semaglutide or placebo with dose escalation for 16 weeks followed by maintenance dose for 88 weeks, alongside dietary and physical activity counseling

104 weeks

Weekly injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Semaglutide

Trial Overview 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.

How Is the Trial Designed?

Group I: Group Teens Experimental Treatment 2 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 Kids Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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

Published Research Related to This Trial

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. Qin, W., Yang, J., Deng, C., et al.[2023]

A survey of 127 physicians revealed that many have varying pre-treatment requirements for prescribing semaglutide for weight loss, with 30% requiring a minimum body mass index of 30 kg/m² and 67% expecting documented lifestyle changes.

Despite its effectiveness, over 50% of patients discontinued semaglutide therapy within the first 3 months, primarily due to cost, perceived lack of effectiveness, and concerns about long-term side effects, indicating a need for better patient education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Semaglutide Use for Weight Management: Practice and Attitudes of Physicians in Israel. Dicker, D., Tamir, O., Lieberman-Segal, G., et al.[2023]

Oral semaglutide significantly reduces HbA1c levels and body weight in patients with type 2 diabetes, showing greater efficacy than placebo and other antidiabetic agents in a review of 11 randomized controlled trials involving 9890 patients.

While oral semaglutide is effective in managing blood glucose and weight, it is associated with increased gastrointestinal side effects like nausea and vomiting, although it has a favorable safety profile regarding severe hypoglycemia and cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral semaglutide for type 2 diabetes: A systematic review and meta-analysis. Avgerinos, I., Michailidis, T., Liakos, A., et al.[2021]

In the SUSTAIN 1 to 5 trials involving 3918 participants with type 2 diabetes, semaglutide significantly helped more individuals achieve their HbA1c targets (47% to 74%) compared to placebo (7% to 19%) and other active comparators (16% to 29%).

Semaglutide was effective in achieving these results while minimizing unwanted outcomes, such as weight gain, severe hypoglycaemia, and gastrointestinal side effects, making it a safer option for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. DeVries, JH., Desouza, C., Bellary, S., et al.[2022]

In two phase III trials involving 2764 participants with overweight or obesity, semaglutide 2.4 mg once weekly significantly improved cardiometabolic risk factors, including reductions in waist circumference, blood pressure, and fasting glucose compared to placebo.

The benefits of semaglutide were not sustained after stopping the treatment, indicating that ongoing administration may be necessary to maintain improvements in health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Kosiborod, MN., Bhatta, M., Davies, M., et al.[2023]

In a 20-week trial with 72 adults, once-weekly subcutaneous semaglutide 2.4 mg significantly reduced appetite and energy intake, leading to a 9.9% reduction in body weight compared to only 0.4% with placebo.

Semaglutide improved participants' control over eating and reduced food cravings without causing delayed gastric emptying, indicating its efficacy in managing obesity without adverse effects on gastric function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Friedrichsen, M., Breitschaft, A., Tadayon, S., et al.[2021]

In a study of 20 patients with type 2 diabetes in Slovenia, oral semaglutide significantly reduced HbA1c levels and fasting plasma glucose, indicating its efficacy in improving glycaemic control.

Patients reported high satisfaction with the treatment, and while some experienced mild gastrointestinal side effects, the overall safety profile was considered good, suggesting that oral semaglutide is a promising option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. Janić, M., Jovanović, M., Janež, A., et al.[2023]

In a phase 3 trial involving 667 adults with overweight or obesity, oral semaglutide 50 mg taken daily resulted in a significant average weight loss of 15.1% compared to only 2.4% with placebo over 68 weeks, demonstrating its efficacy in weight management.

While semaglutide was effective, it was associated with a higher incidence of adverse events, particularly gastrointestinal issues, affecting 80% of participants, indicating that while it is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Knop, FK., Aroda, VR., do Vale, RD., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38471743/

Semaglutide treatment for children with obesity Mean body weight decreased by 9.7±10.8 kg (p<0.001). Percentage total weight loss at 12 months was 8.9±10.0% (p<0.001). Mild gastrointestinal ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38774967/

Semaglutide for management of obesity in adolescents Semaglutide represents an important advance in the pediatric obesity management, with clear short-term reductions in BMI and improvement in ...

3. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7420a1.htm

Prescriptions for Obesity Medications Among Adolescents ... This report describes the proportion of adolescents with obesity who were prescribed an obesity medication during 2018–2023.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2208601

Once-Weekly Semaglutide in Adolescents with Obesity Among adolescents with obesity, once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than ...

5. thinkglobalhealth.org thinkglobalhealth.org/article/how-ozempic-and-glp-1s-are-changing-childhood-and-teen-weight-management

How Ozempic and GLP-1s Are Changing Childhood ... As noted, research from the Journal of the American Medical Association reveals that GLP-1 prescriptions rose 594.4% between 2020 and 2023. Then ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11222026/

Semaglutide for Management of Obesity in Adolescents The purpose of this review is to describe the existing limited data related to the use of semaglutide in adolescents with obesity, supplementing with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05726227

NCT05726227 | A Research Study on How Well ... This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in ...