Liraglutide for Childhood Obesity

Not currently recruiting at 62 trial locations

Overseen By Novo Nordisk

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must not be taking: Obesity medications

Disqualifiers: Type 1 diabetes, Secondary obesity, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 56 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well liraglutide (an injection) can help children with obesity lose weight. Researchers aim to determine the amount of weight loss and any side effects of the medicine. Participants will receive either liraglutide or a placebo (a non-active substance), assigned randomly. The trial is best suited for children aged 6 to under 12 who have struggled to lose weight despite lifestyle changes. Participants will also receive guidance on healthy eating and physical activity. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for childhood obesity.

Do I need to stop my current medications to join the trial?

The trial requires that participants have not taken any medication for obesity in the past 90 days before screening. If you are currently on such medication, you would need to stop it to be eligible.

Is there any evidence suggesting that liraglutide is likely to be safe for children with obesity?

Earlier studies have found liraglutide to be safe for children with obesity. Research shows that after 56 weeks of treatment, most side effects were mild to moderate, and participants generally tolerated the medication well. Common side effects included nausea and vomiting, typical for this type of medicine.

A study with children and teenagers showed that liraglutide not only helped reduce body weight but also improved overall health. Importantly, liraglutide is already approved for adults with obesity, indicating that doctors consider it safe. However, since it is new for children, this study aims to confirm its safety for them. ^{1 2 3 4 5}

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

Liraglutide is unique because it targets childhood obesity through a mechanism that mimics a hormone called GLP-1, which helps regulate appetite and food intake. Researchers are excited about this treatment because unlike traditional options like lifestyle changes and behavioral therapy, liraglutide offers a pharmacological approach that can enhance weight management in children. Additionally, it's administered through a once-daily injection, which might offer a more consistent and manageable treatment routine compared to other therapies that are more demanding in terms of lifestyle changes.

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

Research has shown that liraglutide, which participants in this trial may receive, can help reduce body weight in children with obesity. One study found that after 56 weeks, children who took liraglutide and made lifestyle changes experienced a greater reduction in body weight than those who took a placebo, another treatment option in this trial. Another study found that teenagers who used liraglutide for a year achieved significant weight loss, with more than half losing over 5% of their body weight. However, liraglutide works best for those who adhere to the treatment plan. Overall, these findings suggest liraglutide could be a beneficial option for weight loss in children with obesity. ^{2 6 7 8 9}

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 aged 6 to below 12 with obesity, who haven't had significant weight changes in the last 3 months and have not been on obesity medication recently. They should be struggling to lose weight through lifestyle changes alone. Children with type 2 diabetes can join if their HbA1c levels are low enough.

Inclusion Criteria

Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

I am at any stage of puberty.

History of failing to lose sufficient weight with lifestyle modification as judged by the investigator

Exclusion Criteria

My obesity is caused by a specific medical condition.

I haven't taken obesity medication in the last 90 days.

I have Type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either liraglutide or placebo for weight management, with daily injections and lifestyle counseling

56 weeks

18 visits (in-person), 10 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of BMI and adverse events

26 weeks

4 visits (in-person)

Long-term follow-up

Participants continue to be monitored for long-term safety and health outcomes

14 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liraglutide
• Placebo

Trial Overview Researchers are testing Liraglutide, a new medicine for kids' weight loss, against a placebo (a treatment with no active drug). Participants will receive daily injections and guidance on healthy living over nearly two years, including clinic visits and remote check-ins.

How Is the Trial Designed?

Group I: Liraglutide 3.0 mg Experimental Treatment 1 Intervention

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Group II: Placebo Placebo Group 1 Intervention

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Liraglutide is already approved in United States, European Union for the following indications:

Approved in United States as Victoza for:

• Type 2 diabetes mellitus treatment
• Cardiovascular risk reduction in adults with type 2 diabetes and heart disease

Approved in United States as Saxenda for:

• Weight loss treatment in adults and children aged 12 and older with obesity

Approved in European Union as Victoza for:

• Type 2 diabetes mellitus treatment
• Cardiovascular risk reduction in adults with type 2 diabetes and heart disease

Approved in European Union as Saxenda for:

• Weight loss treatment in adults and children aged 12 and older with obesity

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

Liraglutide, now available at a higher dose of 3.0 mg for treating obesity, has been shown to effectively control appetite and promote weight loss when combined with diet and exercise, based on results from the SCALE studies.

The drug is already established for managing type 2 diabetes at lower doses, and its mechanism of action includes effects on the endocrine pancreas and appetite regulation in the hypothalamus, indicating a dual benefit for patients with obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[LIRAGUTIDE AT A DOSE OF 3.0 MG (SAXENDA): NEW INDICATION FOR THE TREATMENT OF OBESITY]. Scheen, AJ.[2016]

Liraglutide is an FDA-approved GLP-1 receptor agonist for treating type 2 diabetes, administered via subcutaneous injection, and can be used alone or with certain oral medications like metformin or glimepiride.

It is important to note that liraglutide is not recommended as a first-line treatment and is not approved for use in combination with insulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide (Victoza) for type 2 diabetes. [2015]

In a study of 225 patients prescribed Saxenda and Victoza, 96% and 98.7% of prescriptions, respectively, were in line with approved indications, indicating high adherence to guidelines.

Only 5% of patients using Saxenda for 16 weeks or longer were non-adherent to the stopping rule, suggesting that these medications are being used safely and effectively in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the potential non-authorized use of two different formulations of liraglutide in Europe: A real-world drug utilization study. Sbraccia, P., Aberle, J., Olsen, AH., et al.[2023]

Liraglutide (Saxenda) has been shown to effectively promote weight loss in overweight and obese patients, with a higher percentage achieving 5% and 10% weight loss compared to placebo and orlistat, based on randomized controlled studies.

The medication is generally safe, with gastrointestinal side effects being the most common and typically dose-dependent, making it a viable adjunct to lifestyle changes for obesity management, especially in patients with prediabetes and women with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide: an injectable option for the management of obesity. Clements, JN., Shealy, KM.[2022]

Liraglutide, approved for Type 2 diabetes and chronic weight management, works by increasing insulin secretion and decreasing appetite, which helps promote weight loss.

Recent findings suggest that liraglutide may also protect against prediabetes and prevent bone loss by enhancing bone formation after weight loss, highlighting its broader health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide for Type 2 diabetes and obesity: a 2015 update. Iepsen, EW., Torekov, SS., Holst, JJ.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10010327/

Efficacy of Liraglutide in Obesity in Children and Adolescents Liraglutide was not associated with a reduction in pediatric patients' body weight (kg), BMI (kg/m2), or blood pressure (mmHg) in this systematic study.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451847624000150

Efficacy of liraglutide in pediatric obesity: A review ... After 7–8 weeks of treatment, a statistically significant reduction in BMI Z score was observed in the liraglutide-treated group compared with the placebo group ...

3. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2407379

Liraglutide for Children 6 to <12 Years of Age with Obesity Treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions.

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1663499/full

12-month outcomes of GLP - 1 in severe pediatric obesity Among adolescents ≥12 years, 56.5% had a BMI reduction >5% and 43.5% achieved >10% (Figure 2). In adolescents ≥12 years, BMI z-score declined from ...

5. liebertpub.com liebertpub.com/doi/10.1177/21532176251385715

Adherence and Effectiveness of Liraglutide in Adolescents ... Conclusions: Meaningful BMI reduction was observed only in adolescents dispensed ≥7 liraglutide prescriptions. However, only 18% achieved this ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39258838/

Liraglutide for Children 6 to <12 Years of Age with Obesity Conclusions: Among children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12491053/

12-month outcomes of GLP - 1 in severe pediatric obesity Liraglutide was effective and safe in reducing adiposity and improving metabolic health in children and adolescents with severe obesity in a ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1916038

A Randomized, Controlled Trial of Liraglutide for ... In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a significantly greater reduction in the BMI standard-deviation ...

9. bmj.com bmj.com/content/386/bmj.q1998

Liraglutide: Weight loss injection is effective in children ... A BMI reduction of at least 5% occurred in 46% of the children in the liraglutide group but in only 9% of participants in the placebo group ( ...