Brief Summary

This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

316

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach

2 countries

19 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

November 16, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed

1 month until next milestone

Study Start

First participant enrolled

December 22, 2016

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed

Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

November 16, 2016

Last Update Submit

January 19, 2023

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (5)

Number of patients with BMI above or equal to 30 kg/m^2
Less than 6 months before date of first prescription
Number of patients with BMI above or equal to 27kg/m^2 and below 30 kg/m^2 and 1 or more comorbidity
Dysglycaemia (Type 2 Diabetes Mellitus \[T2DM\] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities
Less than 6 months before date of first prescription
Number of patients with above or equal to 27 kg/m^2 and below 30 kg/m^2 and no comorbidities
Dysglycaemia (Type 2 Diabetes Mellitus \[T2DM\] or prediabetes), hypertension, dyslipidaemia, obstructive sleep apnoea, and/or other weight-related comorbidities.
Less than 6 months before date of first prescription
Number of patients with BMI below 27 kg/m^2
Less than 6 months before date of first prescription
Number of patients with BMI not measured
Within 6 months before date of the first prescription

Secondary Outcomes (5)

Number of patients with liraglutide 1.2 or 1.8 mg prescriptions with dose information of 3.0 mg per day
From date of first prescription until 24 months
Number of patients with liraglutide 1.2 or 1.8 mg prescriptions and indication of weight management
From date of first prescription until 24 months
Number of patients with liraglutide 3.0 mg prescriptions who have reached a dose of 3.0 mg
By 12 weeks after first prescription date
Number of patients with liraglutide 3.0 mg prescriptions and other GLP-1 receptor agonists prescribed during continued treatment with liraglutide 3.0 mg
From date of first prescription until 24 months
Number of patients with continued treatment with liraglutide 3.0 mg
From date of first prescription until 0-6 weeks; 7-12 weeks; 13-18 weeks; 19-24 months

Study Arms (1)

liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg

Drug: liraglutide

Interventions

liraglutideDRUG

Patients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients

liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

This is a descriptive study designed to examine in-market utilisation of liraglutide; thus there will be no hypothesis testing and a power calculation is not applicable. 100 patients will be enrolled for the pilot study (50 in each country, ) and additionally 300 patients will be enrolled for the full study (150 in each country)

You may qualify if:

Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as no prescription of the same brand within the previous 12 months)
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability of the study

You may not qualify if:

Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded

Contact the study team to confirm eligibility.