Obesity
Conditions
Brief summary
Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician for the management of obesity. The purpose of this study is to collect data on the effect of Semaglutide under everyday conditions in participants. Participants and doctor had already decided that they will get semaglutide prescribed by doctor, independently of patient's participation in this study. The study will last for 12 months.
Interventions
DRUGSemaglutide
Semaglutide injection will be self-administered once weekly subcutaneously at any time of the day with or without meals.
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
Common inclusion criteria for Group A and Group B: 1. Male or female, age above or equal to 18 years at the time signing informed consent. 2. Body mass index (BMI) more than or equal to (≥) 30 kilogram per meter square (kg/m\^2) with at least one of the following diagnosed obesity-related comorbidities: arterial hypertension, pre-diabetes, Obstructive Sleep Apnea (OSA) or coronary heart disease, chronic heart failure, or BMI ≥35 kg/m\^2. 3. History of at least one self-reported unsuccessful attempt to lose weight. 4. Capable of completing informed consent. Additional inclusion criteria for Group A: 1. The decision to initiate treatment with commercially available Wegovy has been made by the participant and the treating physician before and independently from the decision to include the participant in this study. 2. Initiation of treatment is not modified in any case due to participant's participation in the study. Common
Exclusion criteria
for Group A and Group B: 1. Previous participation in this study (participation is defined as having given informed consent in this study) 2. Treatment with an investigational drug within 30 days prior to enrolment into the study. 3. Participant has had a prior serious allergic reaction to semaglutide or any of the ingredients in Wegovy. 4. Women with pregnancy or breast-feeding. 5. Women of childbearing potential and not using an adequate contraceptive method. 6. Men and women in their pregnancy attempts. 7. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 8. History of any Glucagon-like peptide-1 (GLP-1) treatment within 180 days. 9. History of type 1 or type 2 diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in relative body weight | From baseline to month 6 and month 9 | Percentage (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in relative body weight | From baseline to month 3 and 12 | Percentage (%) |
| Change in body weight | from baseline to month 3, month 6, month 9 and month 12 | Kilogram (Kg) |
| Change in Haemoglobin A1c (HbA1c) | from baseline to month 3, month 6, month 9 and month 12 | millimoles per mole (mmol/mol) |
| Change in fasting plasma glucose (FPG) | from baseline to month 3, month 6, month 9 and month 12 | milligram per deciliter (mg/dL) |
| Change in total cholesterol | from baseline to month 3, month 6, month 9 and month 12 | mg/dL |
| Change in high density lipoprotein (HDL) | from baseline to month 3, month 6, month 9 and month 12 | mg/dL |
| Change in low density lipoprotein (LDL) | from baseline to month 3, month 6, month 9 and month 12 | mg/dL |
| Change in very low density lipoprotein (VLDL) | from baseline to month 3, month 6, month 9 and month 12 | mg/dL |
| Change in lipoprotein A [Lp(a)] | from baseline to month 3, month 6, month 9 and month 12 | mg/dL |
| Change in triglycerides | from baseline to month 3, month 6, month 9 and month 12 | mg/dL |
| Change in estimated glomerular filtration rate (eGFR) eGFR | from baseline to month 3, month 6, month 9 and month 12 | milliliters per minute per 1.73 square meters (mL/min/1.73m²) |
| Change in waist circumference | from baseline to month 3, month 6, month 9 and month 12 | Centimeter (cm) |
| Change in systolic blood pressure (SBP) | from baseline to month 3, month 6, month 9 and month 12 | millimeters of mercury (mmHg) |
| Change in diastolic blood pressure (DBP) | from baseline to month 3, month 6, month 9 and month 12 | mmHg |
| Change in C-reactive protein (CRP) or high-sensitivity C-reactive protein (hs-CRP) | from baseline to month 3, month 6, month 9 and month 12 | milligrams per liter (mg/L) |
| Change in platelet count | from baseline to month 3, month 6, month 9 and month 12 | number of platelets per liter (10\^9/L) |
| Change in gamma-glutamyl transferase (GGT) | from baseline to month 3, month 6, month 9 and month 12 | unit per liter (U/L) |
| Change in alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/GPT) | from baseline to month 3, month 6, month 9 and month 12 | units per liter (U/L) |
| Change in aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/GOT) | from baseline to month 3, month 6, month 9 and month 12 | units per liter (U/L) |
Countries
Germany
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed