Semaglutide for Weight Management in Obesity

No longer recruiting at 1 trial location

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Novo Nordisk A/S

Must be taking: Anti-obesity medications

Disqualifiers: Diabetes, Pregnancy, Hypersensitivity, 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: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests semaglutide, a medication, to evaluate its effectiveness in weight loss compared to other anti-obesity drugs. It also examines how weight loss affects physical health, quality of life, and work performance. Participants will receive either semaglutide or one of four other approved weight-loss medications. Individuals with a BMI of 30 or more who are employed by certain companies may qualify for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader patient population.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that semaglutide is generally safe for weight management. In earlier studies, participants taking a weekly dose of 2.4 mg for obesity lost significant weight without major safety issues. The FDA approved this treatment for weight loss, indicating it passed strict safety tests. Some individuals reported mild side effects like nausea or diarrhea, common with weight loss medications. Overall, semaglutide is considered safe, but discussing any concerns with a healthcare provider before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard anti-obesity medications, which often work by reducing appetite or altering fat absorption, semaglutide is unique because it mimics a hormone called GLP-1 that regulates appetite and food intake. This mechanism can lead to significant weight loss as it helps people feel full with smaller portions. Additionally, semaglutide is administered through a once-weekly injection, which is more convenient compared to some daily oral medications. Researchers are excited about semaglutide because it has shown promising results in helping individuals achieve substantial and sustained weight loss.

What evidence suggests that this trial's treatments could be effective for weight management in obesity?

Research has shown that semaglutide, which participants in this trial may receive, is highly effective for weight loss. In studies, individuals taking semaglutide lost about 14.9% to 17.4% of their body weight. This treatment also reduced waist size and the waist-to-height ratio. Semaglutide mimics a hormone that controls appetite, helping individuals feel full sooner.

In this trial, another group of participants will receive one of four other anti-obesity medications. For comparison, individuals using orlistat lost about 2.61 kg after a year. Phentermine/topiramate users lost up to 13% of their body weight. Naltrexone/bupropion can also lead to significant weight loss, especially with lifestyle changes. Lastly, individuals using liraglutide typically lost 4 to 6 kg over a year. Semaglutide stands out as one of the most effective options available. ^{6 7 8 9 10}

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 people living with obesity in America who are employed by certain companies and expect to stay employed during the study. They must have a BMI of 30 or higher, not have diabetes, and be willing to follow the study rules. Pregnant women or those who could become pregnant without effective contraception are excluded.

Inclusion Criteria

Body mass index (BMI) greater than or equal to 30.0 kilogram per meter square (kg/m^2)

I work for a selected employer and expect to keep my job during the study.

Exclusion Criteria

I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion might jeopardise participant's safety or compliance with protocol.

I am allergic or react badly to Wegovy or similar medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or one of 4 approved anti-obesity medications for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liraglutide
• Naltrexone/Bupropion
• Orlistat
• Phentermine/Topiramate
• Semaglutide

Trial Overview The trial compares the weight loss drug Semaglutide with four other approved medications (Xenical, Qsymia, Contrave, Saxenda) among employees from diverse backgrounds. It aims to assess weight reduction impact on physical function, quality of life, work ability and medication satisfaction.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.

Group II: Other anti-obesity medication Active Control 4 Interventions

Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications are orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.

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

In a 20-week trial with 72 adults, once-weekly subcutaneous semaglutide 2.4 mg significantly reduced appetite and energy intake, leading to a 9.9% reduction in body weight compared to only 0.4% with placebo.

Semaglutide improved participants' control over eating and reduced food cravings without causing delayed gastric emptying, indicating its efficacy in managing obesity without adverse effects on gastric function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating, and gastric emptying in adults with obesity. Friedrichsen, M., Breitschaft, A., Tadayon, S., et al.[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]

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]

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]

In a phase 3 trial involving 667 adults with overweight or obesity, oral semaglutide 50 mg taken daily resulted in a significant average weight loss of 15.1% compared to only 2.4% with placebo over 68 weeks, demonstrating its efficacy in weight management.

While semaglutide was effective, it was associated with a higher incidence of adverse events, particularly gastrointestinal issues, affecting 80% of participants, indicating that while it is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Knop, FK., Aroda, VR., do Vale, RD., et al.[2023]

Semaglutide, a GLP-1 receptor agonist approved for type 2 diabetes, shows superior weight loss efficacy compared to other GLP-1 RAs and has been found safe in clinical trials.

In a phase II trial, once-daily semaglutide demonstrated significant weight loss in patients with obesity (without diabetes), meeting the efficacy criteria for antiobesity drugs set by regulatory agencies, suggesting its potential as a future treatment for obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide as a promising antiobesity drug. Christou, GA., Katsiki, N., Blundell, J., et al.[2020]

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]

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. Qin, W., Yang, J., Deng, C., et al.[2023]

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]

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]

Citations

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Liraglutide for weight management: a critical review of the ... In addition to recommended diet and physical activity, liraglutide consistently resulted in a 4 to 6 kg weight loss, with a greater proportion of patients ...

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Comprehensive analysis of real-world data on liraglutide ... The present study revealed that liraglutide is an effective treatment for adult obesity, achieving 5% weight loss in 76.4% of patients and 10% ...

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One-Year Weight Reduction With Semaglutide or ... Overall, 141 patients (37.4%) receiving semaglutide for obesity achieved 10% or greater body weight reduction vs 223 (16.6%) of those receiving ...

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The effects and side effects of liraglutide as a treatment ... In a long-term clinical study, weight loss due to treatment with 0.3 mg of liraglutide was reported to be 5.4% to 6.0%, which was superior to ...

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Liraglutide (Saxenda) Combined with Lifestyle Coaching ... Weight loss of over 5% is associated with a lower risk of morbidity and mortality and is known to meaningfully improve health-related quality of ...

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Semaglutide - StatPearls - NCBI Bookshelf The FDA issued a postmarket drug safety alert regarding the prevalence of compounded and counterfeit preparations of semaglutide. The increasing ...

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FDA's Concerns with Unapproved GLP-1 Drugs Used for ... FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In ...

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

Chronic Weight Management Trial Results | Wegovy ... Learn about clinical trial results for chronic weight management with Wegovy®. Read important safety and prescribing info, including Boxed Warning.

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

Long-term weight loss effects of semaglutide in obesity ... Semaglutide 2.4 mg safely and effectively produced clinically significant weight loss in all subgroups based on age, sex, race, glycemia, renal ...

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An Assessment of Semaglutide Safety Based on Real World ... An assessment of semaglutide safety based on real world data: from popularity to spontaneous reporting in EudraVigilance database.