Vyvanse for Childhood Obesity

Overseen By Claudia Fox, MD

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must not be taking: Psychostimulants, Antidepressants, Anti-obesity, others

Disqualifiers: Hypertension, Diabetes, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding lisdexamfetamine (Vyvanse) to lifestyle therapy can assist children with severe obesity in maintaining a healthy weight. Participants will receive either lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus a placebo (a substance with no active medication) through random assignment. Children aged 6 to under 12 with severe obesity who have not succeeded with lifestyle changes alone might be suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding how lisdexamfetamine works in children, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that participants stop taking certain medications, such as monoamine oxidase inhibitors, psychostimulants, anti-obesity medications, and some antidepressants, before joining. If you're on any of these, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lisdexamfetamine has been tested for safety in children and teenagers. In these studies, children taking the drug often experienced smaller increases in weight, height, and body mass index compared to those not taking it. Common side effects included reduced appetite, weight loss, and occasionally anxiety or trouble sleeping.

One report noted a serious but non-life-threatening issue in a child, though such cases appear rare. Overall, lisdexamfetamine is generally well-tolerated, as it is already approved for conditions like ADHD. This approval indicates that its safety is mostly understood and acceptable. However, this trial specifically examines the drug's use for childhood obesity, which is a new application. While the drug is generally safe, its effects for this specific purpose are still under investigation. ^{1 2 3 4 5}

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

Researchers are excited about using Lisdexamfetamine Dimesylate for childhood obesity because it offers a novel approach compared to standard lifestyle modifications and medications that primarily focus on diet and exercise. Unlike typical treatments, Lisdexamfetamine is a stimulant that affects certain chemicals in the brain, potentially reducing appetite and helping manage obesity. This mechanism of action is different from current options and may provide an effective alternative for children who struggle with traditional methods. By targeting brain function, it could offer a new way to support weight management in young patients.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research has shown that lisdexamfetamine, also known as Vyvanse, may help children with obesity lose weight. One study demonstrated a noticeable drop in Body Mass Index (BMI) in children taking this medication for up to two years. Another study found it helped young children with severe obesity lose weight. Additionally, reports highlight its use in teenagers dealing with obesity and related issues like binge eating. In this trial, participants will receive either lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. These findings suggest that lisdexamfetamine could effectively help children manage their weight. ^{2 4 5 6 7}

Who Is on the Research Team?

Claudia Fox, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for children aged 6 to <12 with severe obesity, who have tried lifestyle therapy without success. They must not have a history of heart issues, drug abuse, or certain mental health conditions. Girls able to have children must agree to use reliable contraception.

Inclusion Criteria

My BMI is significantly higher than what is considered severely obese for my age.

Written informed consent of parent/legal guardian and written assent of participant

Prior failed attempt of lifestyle therapy per parent/guardian report

Exclusion Criteria

I have diabetes (type 1 or 2).

I am not taking medications like antidepressants, lithium, fentanyl, or St. John's wort.

Thyroid stimulating hormone (TSH) > 1.5x upper limit of normal (ULN)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle therapy
• Lisdexamfetamine Dimesylate

Trial Overview The study tests if adding the medication Vyvanse (lisdexamfetamine) to lifestyle therapy helps kids with severe obesity better than just lifestyle therapy and a placebo. Kids are randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Lifestyle therapy plus lisdexamfetamine Active Control 1 Intervention

Individuals randomized to this arm will receive lifestyle therapy plus lisdexamfetamine for 24 weeks.

Group II: Lifestyle therapy plus placebo Placebo Group 1 Intervention

Individuals randomized to this arm will receive lifestyle therapy plus placebo for 24 weeks.

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

Approved in United States as Lifestyle therapy for:

• Childhood obesity
• Weight management

Approved in European Union as Lifestyle therapy for:

• Childhood obesity
• Weight management

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Obesity in children and adolescents is a complex issue that requires treatment strategies based on the underlying physiology, biochemistry, and genetics, aiming to prevent related health problems and improve quality of life.

Successful obesity treatment should follow a chronic disease model, incorporating a range of approaches including healthy lifestyle changes, pharmacotherapy, and medical devices, while recognizing that bariatric surgery is often not a preferred option for patients and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Options to Treat Pediatric Obesity. Browne, AF.[2017]

Pediatric obesity is a growing global issue, particularly affecting disadvantaged children, and is linked to serious health risks like type 2 diabetes, hypertension, and sleep apnea, stemming from poor lifestyle choices and environmental factors.

Effective interventions require a coordinated effort from governments, communities, and healthcare providers, including public education, school meal reforms, and personalized support for families, as well as new pharmacological approaches targeting appetite control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. Lee, WW.[2007]

Family-based behavioral interventions are effective and safe for treating childhood obesity and should be prioritized as a first-line treatment option.

Primary care providers play a crucial role in identifying childhood obesity early and referring families to evidence-based treatments, emphasizing the importance of comprehensive, family-involved strategies for successful long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]

Family-based lifestyle interventions, including behavioral changes, diet, and exercise, are the primary treatment for childhood obesity, but pharmacologic options like Orlistat and sibutramine are available for severe cases where lifestyle changes have failed.

There is a need for more research on the duration of medical therapy and its combination with lifestyle interventions, as well as addressing the financial barriers families face in accessing these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy in pediatric obesity: current agents and future directions. Wald, AB., Uli, NK.[2021]

Pediatric obesity is a growing public health issue, and effective treatment interventions exist, but many studies have focused on homogeneous groups, often excluding children with psychiatric comorbidities.

Practitioners are encouraged to consider individual and family dynamics when treating overweight children with psychiatric disorders, as these factors can significantly influence treatment success and the prioritization of weight control objectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practitioner review: bridging the gap between research and clinical practice in pediatric obesity. Jelalian, E., Wember, YM., Bungeroth, H., et al.[2015]

Recent advancements in anti-obesity medications (AOMs), particularly glucagon-like peptide 1 receptor agonists and phentermine-topiramate, have shown promising safety and efficacy in treating pediatric obesity, as highlighted by clinical trials since 2020.

A comprehensive treatment approach that combines lifestyle modifications with ongoing pharmacotherapy is essential for improving long-term health outcomes in children and adolescents with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future pharmacotherapies for obesity in children and adolescents. Kelly, AS.[2023]

Childhood obesity interventions aim to regulate body weight and fat while ensuring proper nutrition for growth, with successful programs leading to healthier eating and exercise behaviors that can persist into adulthood.

While these interventions can lead to positive health outcomes like reduced blood pressure and improved insulin sensitivity, they also carry risks such as the potential development of disordered eating patterns, highlighting the need for careful implementation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. Epstein, LH., Myers, MD., Raynor, HA., et al.[2007]

A very-low-energy diet (VLED) has shown promise as an effective alternative for weight reduction and improved blood sugar control in youth with obesity and type 2 diabetes, potentially reducing the need for medications like insulin.

Despite its potential benefits, the long-term safety and adherence challenges of VLED in children and adolescents mean it is not consistently recommended in clinical guidelines, highlighting the need for more extensive research to support its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Perspectives on the Role of Very-Low-Energy Diets in the Treatment of Obesity and Type 2 Diabetes in Youth. Gow, ML., Pham-Short, A., Jebeile, H., et al.[2021]

Current antiobesity medications for children and adolescents, including orlistat, metformin, and sibutramine, show only modest efficacy, and their safety profiles are based on clinical trials that often have methodological limitations.

Most studies assessing these medications have short follow-up periods (typically 1 year or less) and insufficient participant numbers, highlighting the need for larger and longer-term trials to better understand their effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of obesity in children and adolescents: current status and perspectives. Catoira, N., Nagel, M., Di Girolamo, G., et al.[2010]

A review of 27 online continuing medical education (CME) activities on binge-eating disorder (BED) revealed that all were funded by Shire, the manufacturer of Vyvanse (lisdexamfetamine), raising concerns about potential bias in promoting this medication.

The CME modules emphasized the effectiveness of lisdexamfetamine for treating BED while failing to mention serious risks associated with amphetamines, such as addiction and cardiovascular issues, suggesting a focus on promoting the drug rather than providing balanced information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marketing Messages in Continuing Medical Education (CME) Modules on Binge-Eating Disorder (BED). Jung, J., Fugh-Berman, A.[2021]

Lifestyle intervention remains the first step in treating obesity in children and adolescents, while pharmacotherapy is recommended for those over 12 years old as a second step, and bariatric surgery is considered for select cases.

Newly approved drugs for obesity treatment in adolescents have shown both efficacy and safety, expanding the available treatment options and promising more effective management of obesity in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of obesity in children and adolescents: consensus position statement of the Italian society of pediatric endocrinology and diabetology, Italian Society of Pediatrics and Italian Society of Pediatric Surgery. Maffeis, C., Olivieri, F., Valerio, G., et al.[2023]

Lisdexamfetamine, a prodrug that converts to d-amphetamine in the body, effectively treats ADHD by increasing dopamine and noradrenaline levels, as shown in clinical studies conducted in Japan and internationally.

The drug has a favorable safety profile, with most side effects being mild and no increase in adverse events or treatment discontinuation rates observed with long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological properties and clinical effects of the ADHD drug, Lisdexamfetamine (Vyvanse&#174; capsules 20&#8197;mg and 30&#8197;mg)]. Sakai, C.[2020]

Lisdexamfetamine is an effective treatment for ADHD in children and adolescents aged 6 and older, showing greater efficacy than both atomoxetine and OROS-MPH in clinical trials, particularly for those who did not respond well to previous treatments.

The medication is generally well tolerated, with side effects similar to other stimulant medications, making it a viable alternative for patients with inadequate responses to standard ADHD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lisdexamfetamine Dimesylate: A Review in Paediatric ADHD. Frampton, JE.[2018]

Lisdexamfetamine dimesylate is a prodrug stimulant designed for the treatment of ADHD, offering a longer duration of effect and a predictable release of the active drug, d-amphetamine, which helps reduce variability in patient response.

This medication has a lower potential for abuse compared to traditional stimulant medications, making it a safer option for children and adolescents with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lisdexamfetamine in the treatment of adolescents and children with attention-deficit/hyperactivity disorder. Najib, J.[2021]

Lisdexamfetamine (Vyvanse®) is the only FDA-approved medication for treating moderate to severe binge eating disorder (BED) in adults, showing significant reductions in binge eating days per week in two pivotal 12-week phase III studies.

In longer-term studies (up to 52 weeks), lisdexamfetamine not only maintained its efficacy but also reduced the risk of BED relapse, with a tolerability profile similar to that seen in ADHD patients, where most side effects were mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lisdexamfetamine: A Review in Binge Eating Disorder. Heo, YA., Duggan, ST.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40374235/

Weight loss following lisdexamfetamine in children and ... Reduction in BMI for age was noted for up to 2 years following initiation of lisdexamfetamine in children with ADHD and overweight and obesity.

2. liebertpub.com liebertpub.com/doi/abs/10.1177/21532176251385703

Weight Loss Effect of Lisdexamfetamine in Children with ... Conclusions: Lisdexamfetamine was associated with weight loss in young children with severe obesity without genetic syndromes. Further studies ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05416125

NCT05416125 | Vyvanse in Children Aged 6 to 12 Years This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6406487/

Use of Lisdexamfetamine to Treat Obesity in an Adolescent ... In this case report, we describe the use of lisdexamfetamine treatment on an adolescent patient with severe obesity, binge eating disorder and attention ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0890856722002544

Efficacy and Safety of Lisdexamfetamine in Preschool ... A phase 2, open-label study showed that LDX was well tolerated in children aged 4 to 5 years who were diagnosed with ADHD, with reductions in ADHD Rating Scale ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4057639/

A Systematic Review of the Safety of Lisdexamfetamine ... Gains in weight, height, and body mass index were smaller in children and adolescents receiving LDX than in placebo controls or untreated norms. Insomnia was a ...

7. fda.gov fda.gov/media/181673/download

Vyvanse Pediatric Postmarketing Safety Review DPV identified one case with lisdexamfetamine in the U.S. pediatric population reporting a non-fatal serious outcome. The case is summarized ...