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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
Study Summary
This trial will see if semaglutide is better than existing anti-obesity meds in weight loss and quality of life, from a diverse group of participants from 3 US employers.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (≥) 10.0 Percentage (%) (Yes/No)
Secondary outcome measures
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 moreSide effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
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
2019
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,529 Total Patients Enrolled
141 Trials studying Obesity
131,538 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
139,289 Total Patients Enrolled
28 Trials studying Obesity
49,025 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.I am allergic or react badly to Wegovy or similar medications.I am allergic or react badly to all common weight loss drugs.I have a history of diabetes (type 1 or 2).I work for a selected employer and expect to keep my job during the study.You have a body mass index (BMI) of 30 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide
- Group 2: Other anti-obesity medication
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05579249 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this experiment accessible for those seeking treatment?
"Sadly, clinicaltrials.gov reveals that this clinical trial is not presently accepting participants. Initially posted on January 20th of 2023 and recently modified on November 23rd 2022; however, there are currently 956 other trials requiring recruitment efforts which may be more suitable for potential candidates."
Answered by AI
To what extent is Semaglutide considered a secure treatment for patients?
"There is considerable evidence gathered from Phase 4 trials to confirm the safety of Semaglutide, thus it warranted a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
Virginia
California
Other
What site did they apply to?
Nutrition Research Centre
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
Why did patients apply to this trial?
I'm on metformin, which hasn't worked. Would like to get down to a more healthy weight.
PatientReceived 1 prior treatment
Concerned about my weight as labs r now showing pre-diabetic. I am obese and would like to try anything to get back to a healthy weight.
PatientReceived 2+ prior treatments
I want to be healthier and Lise weight. I’m very healthy overall but concerned about my weight.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Novo Nordisk Investigational Site: < 48 hours
Typically responds via
Email
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