NCT07280221Enrolling By InvitationNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Percentage change in body weight
Study Overview
Brief Summary
This study is to investigate the effectiveness and safety of Wegovy (semaglutide) in Korean patients living with obesity in routine clinical practice. The purpose of this study is to investigate the change in body weight and other clinical characteristics related to body weight in patients living with obesity. Participants will be treated with Wegovy (semaglutide) as prescribed by their doctor, in accordance with normal clinical practice. The study will last for about 52 weeks.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Semaglutide (Drug)
Outcomes
Primary Outcomes
Percentage change in body weight
Time Frame: From baseline (week 0) to 24 weeks
Percent (%)
Secondary Outcomes
- Achievement in body weight reduction ≥ 20%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in body composition of Lean body mass(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in body composition of Total fat mass(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in Body mass index (BMI)(From baseline (week 0) up to 8, 16, 24, 32, 40, 52 weeks)
- Absolute change in body weight(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Percentage change in body weight(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Achievement in body weight reduction more than or equal to (≥) 5%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Achievement in body weight reduction ≥ 10%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Achievement in body weight reduction ≥ 15%(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in the proportion of patients by BMI Class I obesity (25 to 29.9 kg/m^2)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in the proportion of patients by BMI Class II obesity (30 to 34.9 kg/m^2)(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)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in waist circumference(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: low-density lipoprotein cholesterol (LDL-C)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: triglycerides (TG)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: free fatty acid (FFA)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in status of type two diabetes mellitus (T2DM)(Baseline (week 0) to 52 weeks [or end of the study (EOS)])
- Change in status of Hypertension(Baseline (week 0) to 52 weeks (or EOS))
- Change in status of Dyslipidemia(Baseline (week 0) to 52 weeks (or EOS))
- Number of treatment-emergent adverse events (TEAEs)(From baseline (week 0) to 52 weeks (or EOS))
- Number of serious TEAEs(From baseline (week 0) to 52 weeks (or EOS))
- Change in cardiometabolic parameters - Systolic blood pressure (SBP)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Diastolic blood pressure (DBP)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Fasting plasma glucose (FPG)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Haemoglobin A1c (HbA1c)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: total cholesterol (TCh)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
- Change in cardiometabolic parameters - Lipids: high-density lipoprotein cholesterol (HDL-C)(From baseline (week 0) to 8, 16, 24, 32, 40, 52 weeks)
Investigators
Study Sites (1)
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