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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
Employed at randomisation by one of the selected employers and expecting to be so for the duration of the study.
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

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I work for a selected employer and expect to keep my job during the study.

Timeline

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

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 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
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
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,488 Previous Clinical Trials
2,377,687 Total Patients Enrolled
134 Trials studying Obesity
125,403 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
84 Previous Clinical Trials
105,410 Total Patients Enrolled
23 Trials studying Obesity
44,362 Patients Enrolled for Obesity

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05579249 — Phase 4
Obesity Research Study Groups: Semaglutide, Other anti-obesity medication
Obesity Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05579249 — Phase 4
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579249 — Phase 4
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?
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
I am obese and would like to try anything to get back to a healthy weight.
PatientReceived no prior treatments
I want to be healthier and Lise weight. I’m very healthy overall but concerned about my weight.
PatientReceived no prior treatments
I am working hard to lose weight. I did not try medications yet. I hope this trial could address my medical condition. Thank you.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
~190 spots leftby Nov 2024