Current partner codePEPTIDESDE
NCT05579249·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

500

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Semaglutide

Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.

DRUG

Orlistat

Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. 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.

DRUG

Phentermine/Topiramate

Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. 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.

DRUG

Naltrexone/Bupropion

Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. 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.

DRUG

Liraglutide

Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. 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.

Timeline

From registration to results.

  1. First posted

    Oct 13, 2022

  2. Study start

    Jan 19, 2023

  3. Primary completion

    Nov 27, 2024

  4. Study completion

    Nov 27, 2024

  5. Results posted

    Jan 14, 2026

  6. Registry updated

    Jan 14, 2026

Outcomes

What the study measures.

Primary outcomes

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)

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

Secondary outcomes

Percentage Change in Body Weight

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

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

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)

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.

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)

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

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)

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

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)

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.

Percentage of Days Covered (PDC) by Study Product

Time frame · From week 0 to week 52

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.

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)

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

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

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

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)).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Nutrition Research Centre

Loma Linda, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

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