WEgovy Real World Assessment of Weight Loss in Korea
WEgovy Real World Assessment of Weight Loss in Korea (WE-WALK): a Multi-centre, Prospective, Single-arm, Nonintervention Study to Investigate the Effectiveness and Safety of Once-weekly Semaglutide 2.4 mg for People Living With Obesity in Routine Clinical Practice in Korea
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Locations
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-
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Daejeon, South Korea, 35220
- Daejeon Endo Internal Medicine Clinic
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- The decision to initiate treatment with commercially available Wegovy (semaglutide) has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
- Initiating treatment with Wegovy (semaglutide) for the first time and according to locally approved label.
- Male or female, aged ≥ 19 years at the time of signing the informed consent.
Exclusion Criteria:
- Previous participation in clinical studies including treatment with Wegovy (semaglutide). Participation is defined as providing informed consent in a previous study.
- Female patient who is pregnant, breast-feeding, or intends to become pregnant and is of childbearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Once weekly Wegovy
Participants will be treated with commercially available semaglutide.
The treating physician will initiate treatment with commercially available semaglutide prior to and independently from the decision to include the participant in the study.
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Semaglutide injection will be self-administered once weekly subcutaneously.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage change in body weight
Time Frame: From baseline (week 0) to 24 weeks
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Percent (%)
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From baseline (week 0) to 24 weeks
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute change in body weight
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
Kilogram (kg)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Percentage change in body weight
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Percent (%)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
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Achievement in body weight reduction more than or equal to (≥) 5%
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Count of patients
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Achievement in body weight reduction ≥ 10%
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Count of patients
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Achievement in body weight reduction ≥ 15%
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
Count of patients
|
From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Achievement in body weight reduction ≥ 20%
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
Count of patients
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in body composition of Lean body mass
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Kg
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in body composition of Total fat mass
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Kg
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in body composition of Lean body mass
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
Percent (%)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in body composition of Total fat mass
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Percent (%)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in Body mass index (BMI)
Time Frame: From baseline (week 0) up to 8, 16, 24, 32, 40, 52 weeks
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Kilogram per meter square (kg/m^2)
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From baseline (week 0) up to 8, 16, 24, 32, 40, 52 weeks
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Change in the proportion of patients by BMI Class I obesity (25 to 29.9 kg/m^2)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Count of patients
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
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Change in the proportion of patients by BMI Class II obesity (30 to 34.9 kg/m^2)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Count of patients
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in the proportion of patients by BMI Class III obesity (≥35 kg/m^2)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Count of patients
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in waist circumference
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Centimetre (cm)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Change in cardiometabolic parameters - Systolic blood pressure (SBP)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Millimetres of mercury (mmHg)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Change in cardiometabolic parameters - Diastolic blood pressure (DBP)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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mmHg
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Change in cardiometabolic parameters - Fasting plasma glucose (FPG)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Milligram per deciliter (mg/dL)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Change in cardiometabolic parameters - Haemoglobin A1c (HbA1c)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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Percent (%)
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
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Change in cardiometabolic parameters - Lipids: total cholesterol (TCh)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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mg/dL
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in cardiometabolic parameters - Lipids: high-density lipoprotein cholesterol (HDL-C)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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mg/dL
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
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Change in cardiometabolic parameters - Lipids: low-density lipoprotein cholesterol (LDL-C)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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mg/dL
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
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Change in cardiometabolic parameters - Lipids: triglycerides (TG)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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mg/dL
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
|
Change in cardiometabolic parameters - Lipids: free fatty acid (FFA)
Time Frame: From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
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mg/dL
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From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks
|
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Change in status of type two diabetes mellitus (T2DM)
Time Frame: Baseline (week 0) to 52 weeks [or end of the study (EOS)]
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Count of patients
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Baseline (week 0) to 52 weeks [or end of the study (EOS)]
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Change in status of Hypertension
Time Frame: Baseline (week 0) to 52 weeks (or EOS)
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Count of patients
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Baseline (week 0) to 52 weeks (or EOS)
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Change in status of Dyslipidemia
Time Frame: Baseline (week 0) to 52 weeks (or EOS)
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Count of patients
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Baseline (week 0) to 52 weeks (or EOS)
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Number of treatment-emergent adverse events (TEAEs)
Time Frame: From baseline (week 0) to 52 weeks (or EOS)
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Count of events
|
From baseline (week 0) to 52 weeks (or EOS)
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Number of serious TEAEs
Time Frame: From baseline (week 0) to 52 weeks (or EOS)
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Count of events
|
From baseline (week 0) to 52 weeks (or EOS)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- NN9536-7850
- U1111-1306-1595 (Other Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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