Semaglutide for Obesity

Not currently recruiting at 118 trial locations

Overseen By Novo Nordisk

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Novo Nordisk A/S

Must be taking: Semaglutide

Must not be taking: Obesity medications

Disqualifiers: Prepubertal, Obesity surgery, Diabetes, others

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well semaglutide (also known as Ozempic, Wegovy, or Rybelsus) can help adolescents with obesity lose weight and maintain weight loss. Participants will receive a weekly injection of semaglutide for at least three years. The injection, using a thin needle, is administered in the stomach, thighs, or upper arms. The trial seeks participants aged 12 to less than 15 years with a body mass index (BMI) at or above the 95th percentile and weighing over 60 kg. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

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 trial.

What is the safety track record for semaglutide?

Research has shown that semaglutide is generally well-tolerated by people with obesity. Studies have found that semaglutide aids in weight loss and lowers the risk of heart problems. For instance, one study reported a 20% decrease in major heart-related events in adults. Another study noted fewer hospital visits for heart failure and fewer deaths due to heart issues. These findings suggest that semaglutide is generally safe for long-term use.

In past trials, semaglutide helped people lose weight and maintain it. Most participants did not experience serious side effects. Common side effects included mild nausea or stomach upset, which usually improved over time.

Overall, the evidence supports semaglutide as a safe option for managing weight, with added benefits for heart health. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Semaglutide is unique because it offers a new approach to treating obesity by mimicking a hormone called GLP-1, which helps control appetite and food intake. Unlike traditional treatments that may rely on lifestyle changes or medications that suppress appetite indirectly, Semaglutide specifically targets the body's natural hormones to reduce hunger more effectively. Additionally, it is administered through a simple weekly injection, which can be more convenient and potentially more consistent for patients compared to daily medication. Researchers are excited because early studies have shown significant weight loss, making it a promising option for those struggling to manage their weight with existing therapies.

What is the effectiveness track record for semaglutide in treating obesity?

Research has shown that semaglutide aids in weight loss. One study found that participants who took semaglutide weekly and made lifestyle changes lost significant weight. Another study reported that 61% of participants lost at least 10% of their body weight after a year of using semaglutide. Additionally, a different analysis revealed that up to 58% of women lost more than 15% of their weight. These findings support the use of semaglutide in managing obesity. ^{3 4 6 7 8}

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 teenagers with excess body weight who are interested in losing and maintaining weight loss. Participants will receive weekly injections of semaglutide for at least 3 years. Specific eligibility criteria details were not provided.

Inclusion Criteria

The parent(s) or legally acceptable representative (LAR) of the participant must sign and date the Informed Consent Form, according to local requirements

BMI greater than or equal to 95th percentile at screening

My body weight is over 60 kg.

Exclusion Criteria

Endocrine, hypothalamic, or syndromic obesity

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

I have not started puberty (Tanner stage 1).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide as a weekly injection to help with weight loss and maintenance

3 years

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Continued Treatment Phase

Participants may continue treatment to maintain weight loss

Up to 6 years

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The study focuses on the effectiveness of semaglutide, administered through weekly injections, in helping overweight adolescents lose and maintain their weight over a minimum period of three years.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

2.4mg or maximum tolerated dose(MTD) injected subcutaneously (under the skin, s.c) once weekly

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

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

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

High-dose once-weekly semaglutide has been shown to significantly reduce weight in patients with obesity or overweight, as demonstrated in four phase 3 clinical trials involving various populations, including those with diabetes.

While gastrointestinal side effects were common, semaglutide was generally well tolerated and also led to improvements in cardiometabolic risk factors, such as waist circumference and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2022]

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.

In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.

Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? Colin, IM., Gérard, KM.[2022]

Semaglutide, a GLP-1 receptor agonist with a long half-life, effectively promotes insulin secretion in a glucose-dependent manner, making it a valuable treatment for type 2 diabetes, approved for use worldwide and in Japan since 2018.

Oral semaglutide (Rybelsus®) is the first GLP-1 receptor agonist available in pill form, showing continuous benefits in glycemic control for patients with type 2 diabetes across various stages, as demonstrated in multiple global clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus&#174; tablets), an oral GLP-1 receptor agonist]. Miyasaka, K.[2022]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[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]

Citations

1. nature.com nature.com/articles/s41591-024-02996-7

Long-term weight loss effects of semaglutide in obesity ... In the SELECT cardiovascular outcomes trial, semaglutide showed a 20% reduction in major adverse cardiovascular events in 17,604 adults with ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2032183

Once-Weekly Semaglutide in Adults with Overweight or ... 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight.

3. prnewswire.com prnewswire.com/news-releases/novo-nordisk-presents-four-new-analyses-on-oral-semaglutide-25-mg-wegovy-in-a-pill-at-obesityweek-2025-including-demonstrated-reductions-in-cardiovascular-risk-factors-302605329.html

Novo Nordisk presents four new analyses on oral ... The percentage of women in the analysis who achieved more than 15% weight loss included: 58.1% (in the pre-menopausal group), 56.5% (in the peri ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823644

One-Year Weight Reduction With Semaglutide or ... However, 61.0% of the patients who received semaglutide for obesity and with persistent coverage at 1 year achieved 10% or greater weight loss, ...

5. novomedlink.com novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/chronic-weight-management.html

Chronic Weight Management Trial Results | Wegovy ... Weight loss in pounds (lb) calculated as 5%, 10%, 15%, and 20% of mean baseline body weight of Wegovy® and placebo patients. Observed data include only ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ... Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39396098/

Semaglutide effects on safety and cardiovascular ... Conclusion: The use of semaglutide reduced 76% in hospitalization due to HF, 17% deaths due to cardiovascular causes, 21% deaths due to any ...

8. ajconline.org ajconline.org/article/S0002-9149(24)00319-9/fulltext

A Systematic Review and Meta-Analysis of Randomized ... Our results suggest that semaglutide is beneficial for promoting sustained weight loss in adults with overweight/obesity and without diabetes.