Semaglutide for Obesity

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Obesity
Semaglutide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this post approval pragmatic clinical study is to see how well semaglutide lowers body weight compared to other medication on the market used to treat obesity, across three US-based employers. These employers represent employees of diverse demography and job functions including hospitality, clerical, administrative, housekeeping, maintenance, and specialised employees across a range of socioeconomic and educational backgrounds. The study will also look at how weight loss affects physical functioning, quality of life and ability to work. It will also gather information on how satisfied participants are with the medication they take. Participants will either receive semaglutide or one of 4 approved anti-obesity medication (Xenical/Qsymia/Contrave/Saxenda).

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: At week 52

At week 52
Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (≥) 10.0 Percentage (%) (Yes/No)
Number of Participants Who Achieve Body Weight Reduction ≥ 15.0% (Yes/No)
Number of Participants Who Achieve Body Weight Reduction ≥ 20.0% (Yes/No)
Number of Participants Who Achieve Change in IWQOL-Lite For CT Physical Function Domain Score Greater Than (>) 14.6 (Yes/No)
Number of Participants Who Are Covered by Study Product ≥ 80% of Days (Yes/No)
Week 52
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
Proportion of Days Covered (PDC) by Study Product

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Overall Study
21%Nausea
12%Decreased Appetite
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Other anti-obesity medication
1 of 2
Semaglutide
1 of 2

Active Control

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide · No Placebo Group · Phase 4

Semaglutide
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Other anti-obesity medicationActiveComparator Group · 4 Interventions: Phentermine/Topiramate, Liraglutide, Orlistat, Naltrexone/Bupropion · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5560

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 52

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,392 Previous Clinical Trials
2,293,493 Total Patients Enrolled
111 Trials studying Obesity
119,069 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
55,601 Total Patients Enrolled
8 Trials studying Obesity
36,352 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) greater than or equal to 30.
You are employed by one of the selected employers and expecting to be so for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.