What side effects are associated with this type of intervention?

Common side effects of GLP-1 receptor agonists like semaglutide include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. These side effects are typically more pronounced at the beginning of the treatment and may decrease over time. Other potential side effects include headache, fatigue, and dizziness. There is also a concern about the risk of thyroid C-cell tumors, so these medications are not recommended for individuals with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. Additionally, some patients may experience injection site reactions.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity, including liraglutide and semaglutide. These medications work by increasing insulin secretion, decreasing glucagon levels, and slowing gastric emptying, which helps reduce appetite and caloric intake. Liraglutide, marketed under the brand name Saxenda, was approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition. Semaglutide, known as Wegovy, has also been approved for weight management in adults with obesity or overweight with related health issues. Both drugs have shown significant efficacy in promoting weight loss in clinical trials.

What other types of research exist?

Promising alternatives to Semaglutide for obesity treatment in 2024 include: 1) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown superior efficacy in weight loss compared to Semaglutide in clinical trials. 2) Exenatide, another GLP-1 receptor agonist, available in extended-release formulations. 3) Ghrelin receptor antagonists, which are under investigation for their potential to reduce appetite and promote weight loss. 4) Anamorelin, a ghrelin mimetic, which is being explored for its effects on weight management in specific conditions like cachexia but may have broader applications.

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Semaglutide for Childhood Obesity (STEP Young Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for obesity, particularly GLP-1 receptor agonists like semaglutide, work by increasing insulin secretion, decreasing glucagon levels, and slowing gastric emptying. These actions collectively reduce appetite and caloric intake, which are crucial for weight loss. For obesity patients, these mechanisms help manage weight by addressing both metabolic and behavioral aspects of eating, leading to more effective and sustained weight loss.

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

Pivotal Trial

Summary

This trial will test if semaglutide helps children and teenagers lose weight. Participants will receive regular injections of semaglutide and will also get advice on healthy eating and physical activity. The study aims to see if semaglutide can help this age group manage their weight better.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 0 to week 111

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Group Kids: Change in body mass index (BMI)

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2021

Completed Phase 4

~5160

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for obesity, particularly GLP-1 receptor agonists like semaglutide, work by increasing insulin secretion, decreasing glucagon levels, and slowing gastric emptying. These actions collectively reduce appetite and caloric intake, which are crucial for weight loss. For obesity patients, these mechanisms help manage weight by addressing both metabolic and behavioral aspects of eating, leading to more effective and sustained weight loss.

Growth differentiation factor 15 (GDF15) and semaglutide inhibit food intake and body weight through largely distinct, additive mechanisms.