Liraglutide for Childhood Obesity

Recruiting at 47 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

78 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug liraglutide for childhood obesity?

Research shows that liraglutide, used under the brand name Saxenda, has been effective in reducing body mass index (BMI) in adolescents with obesity. It works by helping control appetite and has been approved for weight management in adults, suggesting potential benefits for younger populations as well. ^{1 2 3 4 5}

Is liraglutide safe for use in humans?

Liraglutide, known as Victoza for diabetes and Saxenda for weight management, has been shown to be safe in clinical trials for obesity and type 2 diabetes, with studies demonstrating its safety in both adults and adolescents. ^{1 3 4 6 7}

How is the drug liraglutide unique for treating childhood obesity?

Liraglutide is unique because it is a once-daily injection that helps control appetite by acting on the brain, and it was originally used for type 2 diabetes and adult obesity. It is now being explored for childhood obesity, offering a novel approach compared to traditional lifestyle changes alone. ^{1 3 7 8 9}

What is the purpose of this trial?

The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the children will lose, and if there are any side effects. Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day. In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight. The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Liraglutide for Type 2 diabetes and obesity: a 2015 update. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Liraglutide in an Adolescent Population with Obesity: A Randomized, Double-Blind, Placebo-Controlled 5-Week Trial to Assess Safety, Tolerability, and Pharmacokinetics of Liraglutide in Adolescents Aged 12-17 Years. [2022]

3. Belgium pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of liraglutide in Indian adolescents with obesity. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial. [2023]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Liraglutide: an injectable option for the management of obesity. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Liraglutide: a review of its use in the management of obesity. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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