Obesity and Overweight
Conditions
Brief summary
This study is conducted to investigate the safety and effectiveness of semaglutide in participants with obesity and overweight in routine clinical practice. Participants will get semaglutide as prescribed by a doctor. This study will last for about 4 years and participants will participate in the study for approximately 26 weeks.
Interventions
OTHERsemaglutide
Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician.
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Inclusion criteria
1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. The decision to initiate treatment with commercially available semaglutide has been made by the participants and the treating physician before and independently from the decision to include the participant in this study. 3. Male or female adults, age above or equal to 19 years who is scheduled to start treatment with semaglutide based on the clinical judgment of their treating physician as specified in the Korean-prescribing Information (approved label in Korea) at the time of signing informed consent.
Exclusion criteria
1. Participants who are or have previously been on semaglutide therapy before enrollment. 2. Known or suspected hypersensitivity to the active substance or any of the excipients of semaglutide. 3. Previous participation in this study. Participation is defined as having given informed consent in this study. 4. Female participant 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). 5. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (incidence) of AEs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number (incidence) of SAEs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
| Number (incidence) of SADRs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
| Number (incidence) of unexpected AEs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
| Number (incidence) of unexpected ADRs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
| Number (incidence) of unexpected SAEs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
| Number (incidence) of ADRs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
| Total dose of semaglutide | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Milligram/milliliter (mg/mL) |
| Body weight loss | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Percent (%) |
| The proportion of participants losing greater than or equal to 5% body weight | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Percent (%) |
| The proportion of participants losing greater than or equal to 10% body weight | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Percent (%) |
| The proportion of participants losing greater than or equal to 15% body weight | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Percent (%) |
| Number (incidence) of unexpected SADRs | From Visit 1 (baseline, 0 week) to Visit 4 (22 weeks < ~ ≤ 30 weeks) | Count of events |
Countries
South Korea
Outcome results
None listed