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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-8335 | Other Identifier | WHO |
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The study was cancelled prematurely due to lack of patients.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Participants will be treated with commercially available semaglutide along with lifestyle modification in the routine clinical practice. |
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| Group B | Participants with lifestyle modification in the routine clinical practice will be included. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Semaglutide injection will be self-administered once weekly subcutaneously at any time of the day with or without meals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in relative body weight | Percentage (%) | From baseline to month 6 and month 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in relative body weight | Percentage (%) | From baseline to month 3 and 12 |
| Change in body weight | Kilogram (Kg) | from baseline to month 3, month 6, month 9 and month 12 |
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Common inclusion criteria for Group A and Group B:
Male or female, age above or equal to 18 years at the time signing informed consent.
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.
History of at least one self-reported unsuccessful attempt to lose weight.
Capable of completing informed consent.
Additional inclusion criteria for Group A:
Common exclusion criteria for Group A and Group B:
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Two groups of participants are planned to be included, one Group (A) with those initiating semaglutide adjunct with lifestyle modification, and the other Group (B) with those only with lifestyle modification.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR | Berlin | 13597 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Change in Haemoglobin A1c (HbA1c) | millimoles per mole (mmol/mol) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in fasting plasma glucose (FPG) | milligram per deciliter (mg/dL) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in total cholesterol | mg/dL | from baseline to month 3, month 6, month 9 and month 12 |
| Change in high density lipoprotein (HDL) | mg/dL | from baseline to month 3, month 6, month 9 and month 12 |
| Change in low density lipoprotein (LDL) | mg/dL | from baseline to month 3, month 6, month 9 and month 12 |
| Change in very low density lipoprotein (VLDL) | mg/dL | from baseline to month 3, month 6, month 9 and month 12 |
| Change in lipoprotein A [Lp(a)] | mg/dL | from baseline to month 3, month 6, month 9 and month 12 |
| Change in triglycerides | mg/dL | from baseline to month 3, month 6, month 9 and month 12 |
| Change in estimated glomerular filtration rate (eGFR) eGFR | milliliters per minute per 1.73 square meters (mL/min/1.73m²) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in waist circumference | Centimeter (cm) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in systolic blood pressure (SBP) | millimeters of mercury (mmHg) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in diastolic blood pressure (DBP) | mmHg | from baseline to month 3, month 6, month 9 and month 12 |
| Change in C-reactive protein (CRP) or high-sensitivity C-reactive protein (hs-CRP) | milligrams per liter (mg/L) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in platelet count | number of platelets per liter (10^9/L) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in gamma-glutamyl transferase (GGT) | unit per liter (U/L) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/GPT) | units per liter (U/L) | from baseline to month 3, month 6, month 9 and month 12 |
| Change in aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/GOT) | units per liter (U/L) | from baseline to month 3, month 6, month 9 and month 12 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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