A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in Switzerland

Obesity or Overweight Clinical Trial

Official title:

Weight Loss and Treatment Patterns in a Real World Population of Adults Receiving Saxenda® for Weight Management in Routine Clinical Practice in Switzerland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05153590
• Other study ID #: NN8022-4823
• Secondary ID: U1111-1263-5715
• Status: Completed
• Start date: December 3, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: September 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Signed consent (general consent for research or study-specific informed consent) obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• Male or female, aged 18 to 74 years (both inclusive) at the time of Saxenda® initiation.
• Have been prescribed Saxenda® for weight management.
• For the reimbursed cohort, per the Swiss reimbursement criteria: BMI greater than or equal to 35 kg/m^2 or a BMIgreater than or equal to 28 and below 35 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D (Type 2 Diabetes Mellitus), hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
• For the non-reimbursed cohort, BMI greater than or equal to 30 kg/m^2 or a BMI greater than or equal to 28 kg/m^2 with additional weight related comorbidities (pre diabetes or T2D, arterial hypertension, dyslipidaemia), prior to receiving the Saxenda® treatment.
• The decision to initiate treatment with commercially available Saxenda® has been made by the patient/legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
• Baseline weight measurement within 3 months of Saxenda® initiation/prescription.
• At least one weight assessment post-Saxenda® initiation/prescription.

Exclusion Criteria:

• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Treatment with any investigational drug within 30 days of Saxenda® prescription/initiation.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Concomitant treatment of Saxenda® with other GLP 1 (Glucagon-like peptide-1) receptor agonists, or orlistat.
• Concomitant treatment with sodium/glucose cotransporter-2 inhibitors (SGLT 2i), dipeptidyl peptidase-4 (DPP 4i), or insulin for the reimbursed cohort only.
• Patients who have been treated with any obesity medication for last 12 weeks prior to initiation of Saxenda® treatment.
• Patients who have previously been treated with a GLP 1 receptor agonist for the reimbursed cohort only.
• Patients who have undergone bariatric surgery at any time before starting Saxenda® treatment.
• Patients initiating Saxenda® treatment after 31 October 2020.

Related Conditions & MeSH terms

• Obesity or Overweight
• Overweight
• Weight Loss

Intervention

Drug:
• Saxenda®
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.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Soeborg

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Reimbursed setting: Absolute change in body weight	messured in kg	From Baseline (Week 0) to Week 16
Secondary	Reimbursed setting: Relative change in body weight	messured in percent	From Baseline (Week 0) to Week 16
Secondary	Reimbursed setting: Absolute change in body weight	messured in kg	From Week 16 to Month 10
Secondary	Reimbursed setting: Relative change in body weight	messured in percent	From Week 16 to Month 10
Secondary	Reimbursed setting: Absolute change in body weight	messured in kg	From Baseline (Week 0) to Month 10
Secondary	Reimbursed setting: Relative change in body weight	messured in percent	From Baseline (Week 0) to Month 10
Secondary	Reimbursed setting: Time on Saxenda®	messured in day	From Baseline (Week 0) to end of study date
Secondary	Reimbursed setting: Discontinuation of patient (yes/no)	Percentage of patients - yes/no	From Baseline (Week 0) to Week 16
Secondary	Reimbursed setting: Discontinuation of patient (yes/no)	Percentage of patients - yes	From Week 16 to Month 10
Secondary	Reimbursed setting: Discontinuation of patient (yes/no)	Percentage of patients - yes	From Baseline (Week 0) to Month 10
Secondary	Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)	Percentage of patients - yes	Baseline
Secondary	Non-reimbursed setting: Time on Saxenda®	messured in Day	From Baseline (Week 0) to end of study date
Secondary	Non-reimbursed setting: Discontinuation of patient (yes/no)	Percentage of patients - yes	From Baseline (Week 0) to Week 16
Secondary	Non-reimbursed setting: Discontinuation of patient (yes/no)	Percentage of patients - yes	From Week 16 to Month 10
Secondary	Non-reimbursed setting:Discontinuation of patient (yes/no)	Percentage of patients - yes	From Baseline (Week 0) to Month 10
Secondary	Non-reimbursed setting: Discontinuation of patient (yes/no)	Percentage of patients - yes	From Baseline (Week 0) to end of study date
Secondary	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