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

NCT05153590 | Completed

• 2 other identifiers: NN8022-4823U1111-1263-5715
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity or Overweight

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (17)

• Reimbursed setting: Absolute change in body weight

  From Baseline (Week 0) to Week 16

• Reimbursed setting: Relative change in body weight

  From Baseline (Week 0) to Week 16

• Reimbursed setting: Absolute change in body weight

  From Week 16 to Month 10

• Reimbursed setting: Relative change in body weight

  From Week 16 to Month 10

• Reimbursed setting: Absolute change in body weight

  From Baseline (Week 0) to Month 10

Study Arms (2)

Reimbursed

The reimbursed cohort includes only patients who received Saxenda® through mandatory basic insurance

Drug: Saxenda®

Non reimbursed

The non reimbursed cohort includes patients who received Saxenda® through additional private insurance or self-pay

Drug: Saxenda®

Interventions

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.

Non reimbursed; Reimbursed

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Soeborg, 2860, Denmark

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 10, 2021
• Study Start: December 3, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)