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NCT Number: NCT05153590

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

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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Key information

Conditions

Obesity or Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Soeborg, 2860, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

    Time frame: From Baseline (Week 0) to Week 16

    Percentage of patients - yes

  2. 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)

    Time frame: From Week 16 to Month 10

    Percentage of patients - yes

Secondary outcomes

  1. Reimbursed setting: Absolute change in body weight

    Time frame: From Baseline (Week 0) to Week 16

    messured in kg

  2. Reimbursed setting: Relative change in body weight

    Time frame: From Baseline (Week 0) to Week 16

    messured in percent

  3. Reimbursed setting: Absolute change in body weight

    Time frame: From Week 16 to Month 10

    messured in kg

  4. Reimbursed setting: Relative change in body weight

    Time frame: From Week 16 to Month 10

    messured in percent

  5. Reimbursed setting: Absolute change in body weight

    Time frame: From Baseline (Week 0) to Month 10

    messured in kg

  6. Reimbursed setting: Relative change in body weight

    Time frame: From Baseline (Week 0) to Month 10

    messured in percent

  7. Reimbursed setting: Time on Saxenda®

    Time frame: From Baseline (Week 0) to end of study date

    messured in day

  8. Reimbursed setting: Discontinuation of patient (yes/no)

    Time frame: From Baseline (Week 0) to Week 16

    Percentage of patients - yes/no

  9. Reimbursed setting: Discontinuation of patient (yes/no)

    Time frame: From Week 16 to Month 10

    Percentage of patients - yes

  10. Reimbursed setting: Discontinuation of patient (yes/no)

    Time frame: From Baseline (Week 0) to Month 10

    Percentage of patients - yes

  11. Reimbursed setting: Presence of obesity-related comorbidities identified by authorities (*pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)

    Time frame: Baseline

    Percentage of patients - yes

  12. Non-reimbursed setting: Time on Saxenda®

    Time frame: From Baseline (Week 0) to end of study date

    messured in Day

  13. Non-reimbursed setting: Discontinuation of patient (yes/no)

    Time frame: From Baseline (Week 0) to Week 16

    Percentage of patients - yes

  14. Non-reimbursed setting: Discontinuation of patient (yes/no)

    Time frame: From Week 16 to Month 10

    Percentage of patients - yes

  15. Non-reimbursed setting:Discontinuation of patient (yes/no)

    Time frame: From Baseline (Week 0) to Month 10

    Percentage of patients - yes

  16. Non-reimbursed setting: Discontinuation of patient (yes/no)

    Time frame: From Baseline (Week 0) to end of study date

    Percentage of patients - yes

  17. Non-reimbursed setting: Presence of obesity-related comorbidities identified by the authorities (pre-diabetes, type 2 diabetes, dyslipidaemia and hypertension)

    Time frame: Baseline

    Percentage of patients - yes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2021
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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