Clinical trial NCT05153590: A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in Switzerland
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity or Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: From Baseline (Week 0) to Week 16
measure: 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)
timeFrame: From Week 16 to Month 10
Secondary outcomes:
measure: Reimbursed setting: Absolute change in body weight
timeFrame: From Baseline (Week 0) to Week 16
measure: Reimbursed setting: Relative change in body weight
timeFrame: From Baseline (Week 0) to Week 16
measure: Reimbursed setting: Absolute change in body weight
timeFrame: From Week 16 to Month 10
measure: Reimbursed setting: Relative change in body weight
timeFrame: From Week 16 to Month 10
measure: Reimbursed setting: Absolute change in body weight
timeFrame: From Baseline (Week 0) to Month 10
measure: Reimbursed setting: Relative change in body weight
timeFrame: From Baseline (Week 0) to Month 10
measure: Reimbursed setting: Time on Saxenda®
timeFrame: From Baseline (Week 0) to end of study date
measure: Reimbursed setting: Discontinuation of patient (yes/no)
timeFrame: From Baseline (Week 0) to Week 16
measure: Reimbursed setting: Discontinuation of patient (yes/no)
timeFrame: From Week 16 to Month 10
measure: Reimbursed setting: Discontinuation of patient (yes/no)
timeFrame: From Baseline (Week 0) to Month 10
measure: Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)
timeFrame: Baseline
measure: Non-reimbursed setting: Time on Saxenda®
timeFrame: From Baseline (Week 0) to end of study date
measure: Non-reimbursed setting: Discontinuation of patient (yes/no)
timeFrame: From Baseline (Week 0) to Week 16
measure: Non-reimbursed setting: Discontinuation of patient (yes/no)
timeFrame: From Week 16 to Month 10
measure: Non-reimbursed setting:Discontinuation of patient (yes/no)
timeFrame: From Baseline (Week 0) to Month 10
measure: Non-reimbursed setting: Discontinuation of patient (yes/no)
timeFrame: From Baseline (Week 0) to end of study date
measure: Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)
timeFrame: Baseline
Other outcomes:
Locations:
city: Soeborg
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: