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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1263-5715 | Other Identifier | World Health Organization (WHO) |
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The study is investigating weight loss and treatment patterns associated with the use of Saxenda® in adult patients.
The aim of the study is to assess the weight loss associated with Saxenda® in patients with obesity or overweight. Saxenda® was prescribed to participants by study doctor independently of this study.
The study will last for about 4 months, where the data will be collected from the available medical records.
There will be no additional activities expected from participants in the scope of study because it is a chart-review study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reimbursed | The reimbursed cohort includes only patients who received Saxenda® through mandatory basic insurance |
| |
| Non reimbursed | The non reimbursed cohort includes patients who received Saxenda® through additional private insurance or self-pay |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxenda® | Drug | Patients will be treated with commercially available Saxenda® according to local label and to routine clinical practice at the discretion of the treating physician. The indication is for adults who need help managing their weight based on two different body mass index (BMI) groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight greater than or equal to 5% (lower BMI with weight related comorbidities) or greater than or equal to 7% (higher BMI) in reimbursed setting (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to Week 16 |
| Relative change in body weight greater than or equal to 5%, conditionally to relative change greater than or equal to 5% or greater than or equal to 7% at Week 16 in reimbursed setting(yes/no) | Percentage of patients - yes | From Week 16 to Month 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Reimbursed setting: Absolute change in body weight | messured in kg | From Baseline (Week 0) to Week 16 |
| Reimbursed setting: Relative change in body weight | messured in percent |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of male or female adults who have been prescribed Saxenda® for weight management in 2 cohorts reimbursed and non reimbursed
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Soeborg | 2860 | Denmark |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| From Baseline (Week 0) to Week 16 |
| Reimbursed setting: Absolute change in body weight | messured in kg | From Week 16 to Month 10 |
| Reimbursed setting: Relative change in body weight | messured in percent | From Week 16 to Month 10 |
| Reimbursed setting: Absolute change in body weight | messured in kg | From Baseline (Week 0) to Month 10 |
| Reimbursed setting: Relative change in body weight | messured in percent | From Baseline (Week 0) to Month 10 |
| Reimbursed setting: Time on Saxenda® | messured in day | From Baseline (Week 0) to end of study date |
| Reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes/no | From Baseline (Week 0) to Week 16 |
| Reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Week 16 to Month 10 |
| Reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to Month 10 |
| Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension) | Percentage of patients - yes | Baseline |
| Non-reimbursed setting: Time on Saxenda® | messured in Day | From Baseline (Week 0) to end of study date |
| Non-reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to Week 16 |
| Non-reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Week 16 to Month 10 |
| Non-reimbursed setting:Discontinuation of patient (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to Month 10 |
| Non-reimbursed setting: Discontinuation of patient (yes/no) | Percentage of patients - yes | From Baseline (Week 0) to end of study date |
| Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension) | Percentage of patients - yes | Baseline |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |