A Non-interventional Study Investigating Semaglutide in Combination With Lifestyle-based Modifications for the Management of Obesity in Real-World Clinical Practice in Germany (WeGo Real Germany).
- Registration Number
- NCT07081178
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 555
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group A Semaglutide Participants will be treated with commercially available semaglutide along with lifestyle modification in the routine clinical practice.
- Primary Outcome Measures
Name Time Method Change in relative body weight From baseline to month 6 and month 9 Percentage (%)
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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)