Semaglutide for Obesity

No longer recruiting at 204 trial locations

Overseen By Novo Nordisk

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Disqualifiers: Joint replacement, Diabetes, Pregnancy, 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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 68 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well the medication semaglutide aids people with obesity who also suffer from knee osteoarthritis, a condition causing joint pain and stiffness. The researchers aim to determine if semaglutide can reduce body weight and knee pain compared to a placebo, or "dummy" medicine. Participants will receive weekly injections and follow a healthy diet and exercise plan. The study seeks individuals with a Body Mass Index (BMI) of 30 or more who experience knee pain due to osteoarthritis. Participants must not have had knee joint replacements or other recent knee treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 take pain medications for 3 days before 6 of the clinic visits.

Is there any evidence suggesting that semaglutide is likely to be safe for humans?

Research shows that semaglutide is generally well-tolerated. Previous studies identified the most common side effects as stomach and intestinal issues, such as nausea, vomiting, and diarrhea, which often improved after a few weeks.

Reports also mention more serious side effects, like inflammation of the pancreas, a gland behind the stomach that aids digestion. However, these are less common. Studies suggest that dietary and lifestyle changes can help manage some side effects.

The FDA has already approved semaglutide for other uses, indicating its safety has been tested in many people. This provides some reassurance about its safety for the condition under study. However, it's important to remember that everyone is different, and side effects can vary from person to person. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Semaglutide is unique because it targets obesity and knee osteoarthritis with a dual approach. Unlike traditional treatments that often focus on either weight management or pain relief separately, semaglutide, a GLP-1 receptor agonist, tackles both issues simultaneously by promoting weight loss and potentially reducing inflammation. This once-weekly injection, combined with lifestyle changes like a reduced-calorie diet and exercise, offers a fresh and potentially more effective way to manage these conditions together. Researchers are excited about semaglutide because it not only helps with significant weight loss but also has the potential to improve joint health, which is a game-changer for people suffering from these interconnected issues.

What evidence suggests that semaglutide might be an effective treatment for weight loss and knee pain?

Research has shown that semaglutide can aid in weight loss. One study found that participants taking semaglutide lost an average of 14.9% of their body weight over 68 weeks, compared to only 2.4% for those on a placebo. Another study demonstrated that semaglutide helped maintain weight loss for four years. In this trial, participants will receive either semaglutide 2.4 mg or a placebo as part of different treatment arms. These findings suggest that semaglutide could alleviate obesity-related issues, such as knee pain, by reducing weight. ^{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?

Inclusion Criteria

Body Mass Index (BMI) equal to or greater than 30.0 kg/m^2

Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) with moderate radiographic changes (Kellgren-Lawrence (KL) grades 2 or 3 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees are equal target knee joint will be in the most dominant leg.

Pain due to knee OA

Exclusion Criteria

Joint replacement in target knee

Arthroscopy or injections into target knee within last 3 months prior to enrolment

Any other joint disease in the target knee

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 semaglutide or placebo injections once weekly, with dietary and physical activity counseling

68 weeks

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

How Is the Trial Designed?

Group I: semaglutide 2.4 mg Experimental Treatment 1 Intervention

Participants will receive semaglutide subcutaneous (s.c) 2.4 mg once-weekly as adjunct to a reduced-calorie diet and increased physical activity

Group II: semaglutide 2.4 mg (placebo) Placebo Group 1 Intervention

Participants will receive semaglutide subcutaneous (s.c) placebo once-weekly as adjunct to a reduced-calorie diet and increased physical activity

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, particularly at doses of 14 mg or flexibly dosed, significantly reduced HbA1c levels and body weight in patients with type 2 diabetes compared to other treatments, especially in those with higher baseline HbA1c levels.

The safety profile of oral semaglutide was comparable to that of other treatments, although it was associated with a higher incidence of gastrointestinal adverse events, which were consistent across different patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Aroda, VR., Bauer, R., Christiansen, E., et al.[2022]

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]

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 (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.

The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. Dhillon, S.[2019]

In a 52-week study involving 731 patients with type 2 diabetes, oral semaglutide significantly reduced HbA1c levels and body weight compared to placebo, demonstrating its efficacy when added to insulin with or without metformin.

The most common side effect of oral semaglutide was nausea, which was mostly mild to moderate, indicating a safety profile similar to other glucagon-like peptide 1 receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Zinman, B., Aroda, VR., Buse, JB., et al.[2022]

Semaglutide, a GLP-1 receptor agonist for type 2 diabetes, has a good safety profile but is associated with a high prevalence of gastrointestinal disorders, reported in over 3500 cases (53.2%).

Compared to other diabetes medications like sitagliptin and empagliflozin, semaglutide has a significantly higher number of reported gastrointestinal adverse events, indicating the need for careful monitoring in certain patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database. Cabral Lopes, A., Roque, F., Lourenço, O., et al.[2023]

Citations

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Obesity rate is declining as more Americans use weight ...

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Semaglutide produced clinically significant weight loss and improvements in anthropometric measurements versus placebo. Weight loss was sustained over 4 years.

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The mean change in body weight from baseline to week 68 was −14.9% in the semaglutide group as compared with −2.4% with placebo, for an ...

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thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(25)01375-3/fulltext

Semaglutide and cardiovascular outcomes by baseline ...

The SELECT trial found semaglutide reduced major adverse cardiovascular events (MACE) in patients with overweight or obesity with ...

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Safety data from RYBELSUS ® (semaglutide) clinical trials

The most frequently reported adverse reactions were GI disorders, including nausea, abdominal pain, and diarrhea · Nausea, vomiting, and/or diarrhea occurred ...

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ozempic.com

ozempic.com/how-to-take/side-effects.html

Possible Side Effects of Ozempic ® (semaglutide) Injection

Ozempic® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using Ozempic® and call your health care provider right ...

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fda.gov

fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ...

605 reports of adverse events associated with compounded semaglutide. 545 reports of adverse events associated with compounded tirzepatide.

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goodrx.com

goodrx.com/ozempic/semaglutide-side-effects?srsltid=AfmBOor34-f95bA3tyRmMhQ1yu82X-py7yfKrnFN9GTbM4syYUoMXiS_

19 Semaglutide (Ozempic, Wegovy) Side Effects You ...

Nausea, vomiting, and diarrhea are the most common semaglutide side effects. But they usually improve after a few weeks. Dietary and lifestyle changes can help ...

10.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK603723/

Semaglutide - StatPearls - NCBI Bookshelf

Due to a heightened risk of gastrointestinal adverse effects such as nausea, vomiting, diarrhea, and constipation, close monitoring of patients ...