What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists like semaglutide, often have side effects including gastrointestinal issues (nausea, vomiting, diarrhea, and constipation). There are also potential risks of pancreatitis and, in rare cases, thyroid C-cell tumors. Other anti-obesity medications like Xenical (orlistat) can cause gastrointestinal side effects such as oily stools and flatulence, while medications like Qsymia (phentermine/topiramate) may lead to increased heart rate, insomnia, and mood changes. Contrave (naltrexone/bupropion) can cause nausea, constipation, headache, and dizziness, and Saxenda (liraglutide) shares similar side effects with semaglutide, including gastrointestinal discomfort and potential risks for pancreatitis and thyroid tumors.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity, including liraglutide and semaglutide. These medications work by increasing insulin secretion, decreasing glucagon levels, and slowing gastric emptying, which helps promote weight loss. Liraglutide, marketed as Saxenda, was approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition. Semaglutide, marketed as Wegovy, has also been approved for weight management in adults with obesity or overweight with related health conditions. These drugs are part of a broader category of incretin-based therapies that have shown efficacy in weight reduction and improved metabolic control.

What other types of research exist?

Promising novel alternatives to Semaglutide for obesity treatment in 2024 include Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown significant weight loss in clinical trials. Another alternative is Cagrilintide, an amylin analog that can be used in combination with GLP-1 receptor agonists to enhance weight loss. Additionally, Setmelanotide, a melanocortin 4 receptor (MC4R) agonist, is being explored for specific genetic forms of obesity and has shown promising results.

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Glucagon-like peptide-1 receptor agonist

Semaglutide for Weight Management in Obesity

Phase 4

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 52

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests how well semaglutide helps employees from various backgrounds lose weight compared to other weight-loss medications. It works by making people feel less hungry so they eat less. Semaglutide has been widely studied and approved for chronic weight management due to its efficacy in promoting significant weight loss by suppressing appetite and reducing energy intake.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include digestive issues like nausea and diarrhea; headaches; potential allergic reactions; mood changes; heart palpitations. Each medication has its own profile of side effects that can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (≥) 10.0 Percentage (%) (Yes/No)

Secondary study objectives

Change in Body Weight

Change in Impact of Weight on Quality of Life-Lite For Clinical Trials (IWQOL-Lite-CT) Physical Function Domain

Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score

+5 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SemaglutideExperimental Treatment1 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 medicationActive Control4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as GLP-1 receptor agonists like semaglutide, work by increasing insulin secretion, decreasing glucagon levels, and slowing gastric emptying. These mechanisms help regulate blood sugar levels, reduce appetite, and promote a feeling of fullness, which collectively contribute to weight loss. This is particularly important for obesity patients as it addresses both metabolic and behavioral aspects of weight management, leading to improved physical functioning, quality of life, and overall health outcomes.