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Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America

NCTNCT05579249 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4741Other idU1111-1263-7301
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
500 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
19 Jan 2023
Primary completion
27 Nov 2024
Completion
27 Nov 2024
First posted
13 Oct 2022
Last update posted
14 Jan 2026
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 4

    A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America

    NCT05579249

    19 Jan 2023 to 27 Nov 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • SemaglutideDrug
  • OrlistatDrug
  • Phentermine/TopiramateDrug
  • Naltrexone/BupropionDrug
  • LiraglutideDrug

Arms2

  • Experimental

    Semaglutide

    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.

  • Active comparator

    Other anti-obesity medication

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)

    Time frame · At end of treatment (week 52)

    Registry description

    Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented.

Secondary outcomes(8)

  1. Percentage Change in Body Weight

    Time frame · Baseline (week 0), end of treatment (week 52)

    Registry description

    Percentage change in body weight from week 0 to week 52 is presented.

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

    Time frame · Baseline (week 0), end of treatment (week 52)

    Registry description

    The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain.

  3. Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)

    Time frame · At end of treatment (week 52)

    Registry description

    Number of participants who achieved more than or equal to 15.0% body weight reduction (yes/no) at week 52 is presented.

  4. Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)

    Time frame · At end of treatment (week 52)

    Registry description

    Number of participants who achieved more than or equal to 20.0% body weight reduction (yes/no) at week 52 is presented.

  5. Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)

    Time frame · At end of treatment (week 52)

    Registry description

    The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain score ≥ 14.6.

  6. Percentage of Days Covered (PDC) by Study Product

    Time frame · From week 0 to week 52

    Registry description

    Percentage of days covered by study product from week 0 to week 52 is presented. The percentage of days covered by the study product is determined by the duration on the study product divided by the planned study duration, multiplied by 100.

  7. Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)

    Time frame · At end of treatment (week 52)

    Registry description

    Number of participants covered by study product ≥80% of days (yes/no) from week 0 to week 52 is presented.

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

    Time frame · Baseline (week 0), end of treatment (week 52)

    Registry description

    Work Limitations Questionnaire (WLQ-25) is a 25-item questionnaire that measures how health problems affect job performance and productivity over the past two weeks, using a 5-point Likert scale. It covers four domains: Time Management (5 items), Physical Demands (6), Mental/Interpersonal (9), and Output Demands (5). Each item is scored from 1 to 5, with subscale scores calculated as the average item score, then converted to a 0-100 scale using the formula: WLQ Scale Score= 25 × (average item score - 1). Thus, each subscale ranges from 0 (no limitation) to 100 (maximum limitation). The WLQ total score is computed by applying specific weights to each subscale and summing them: 0.00048 × Time scale + 0.00036 × Physical scale + 0.00096 × Mental/Interpersonal scale + 0.00106 × Output scale. This total is then transformed into the proportion of productivity loss using the formula: (1 - exp(-total score)).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· At end of treatment (week 52)

Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg132
Other Anti-obesity Medications (AOMs)61
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (week 0), end of treatment (week 52)

Percentage Change in Body Weight

GroupValue (Percentange change in body weight)Spread
Semaglutide 2.4 mg-13.68.7
Other Anti-obesity Medications (AOMs)-7.47.3
Secondary outcomeMean· Baseline (week 0), end of treatment (week 52)

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

GroupValue (Score on a scale)Spread
Semaglutide 2.4 mg25.621.2
Other Anti-obesity Medications (AOMs)22.624.4
Secondary outcomeCount of participants· At end of treatment (week 52)

Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg93
Other Anti-obesity Medications (AOMs)25
Secondary outcomeCount of participants· At end of treatment (week 52)

Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg49
Other Anti-obesity Medications (AOMs)8
Secondary outcomeCount of participants· At end of treatment (week 52)

Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg138
Other Anti-obesity Medications (AOMs)108
Secondary outcomeMean· From week 0 to week 52

Percentage of Days Covered (PDC) by Study Product

GroupValue (Percentage of days covered)Spread
Semaglutide 2.4 mg83.724.6
Other Anti-obesity Medications (AOMs)70.828.6
Secondary outcomeCount of participants· At end of treatment (week 52)

Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg168
Other Anti-obesity Medications (AOMs)113

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 2.4 mgParticipants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management.0 / 2503 / 2420 / 242
Other Anti-obesity Medications (AOMs)Participants received 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 were 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.2 / 2508 / 2420 / 242

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Body mass index (BMI) greater than equal to 30.0 kilogram per meter square (kg/m\^2). * Employed at randomisation by one of the selected employers and expecting to be so for the duration of the study. Exclusion Criteria: * Known or suspected hypersensitivity or contraindications to Wegovy or related products according to the label. * Known or suspected hypersensitivity or contraindications to all of the other Anti-Obesity Medications (AOMs) for chronic weight management (Xenical, Qsymia, Contrave, and Saxenda) or related products according to the labels. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * History of type 1 or type 2 diabetes mellitus. * Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion might jeopardise participant's safety or compliance with protocol.

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