NN8022-4241 In-market utilisation of liraglutide used for weight management in Europe: a retrospective medical record review study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post Authorisation Safety Study (PASS)

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LIRAGLUTIDE
• Medical condition to be studied:
  Obesity

Population studied

• Short description of the study population:
  To be eligible for this full study, patients were required to meet both of the following inclusion criteria:; 1. Initiation of Saxenda® or Victoza® (initiation is defined as no prescription of the same brand within the previous 12 months).; 2. Informed consent obtained before any study-related activities. Study-related activities (e.g. data collection) are any procedures that are carried out as part of the study, including activities to determine suitability of the study. ; Exclusion criteria:; 1. Patients or physicians who previously participated in interventional programs for Saxenda® or Victoza® will not be eligible to participate in the study.; 2. For the full study, sites and patients included in the pilot will be excluded.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  316

Study design details

• Main study objective:
  To assess the use of Saxenda® according to the approved indication
• Outcomes:
  Number of p with BMI above or equal to 30 kg/m^2Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidityNumber of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbiditiesNumber of patients with BMI below 27 kg/m^2Number of patients with BMI not measured, See attached protocol
• Data analysis plan:
  As this is a descriptive study that will investigate in-market utilisation of liraglutide, no formal statistical testing will be conducted.

Documents

Study results

4241-nsr-nn-trials-redacted