A Regulatory Post-marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda®(Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea.

July 8, 2021 updated by: Novo Nordisk A/S

Prospective, Multicentre, Open-label, Single-arm, Non-interventional Regulatory Post-marketing Surveillance(rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda® (Liraglutide 3.0 mg) in Obese Patients and Overweight Patients With Obesity-related Comorbidities in Routine Clinical Practice in Korea

The purpose of this study is to collect information about the safety and effectiveness of Saxenda® in obese patients and overweight patients with obesity-related comorbidities. The participant will attend the clinic or hospital according to usual practice and receive medical care, as agreed with the study doctor. The participation is expected to be approximately for 26 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

758

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 49267
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 47360
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 48107
        • Novo Nordisk Investigational Site
      • Busan, Korea, Republic of, 49201
        • Novo Nordisk Investigational Site
      • Daegu, Korea, Republic of, 42601
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 361-711
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 302-718
        • Novo Nordisk Investigational Site
      • Gangwon-do, Korea, Republic of, 26426
        • Novo Nordisk Investigational Site
      • Gwangju, Korea, Republic of, 12756
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 10475
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 15355
        • Novo Nordisk Investigational Site
      • Gyeonggi-do, Korea, Republic of, 13120
        • Novo Nordisk Investigational Site
      • Incheon, Korea, Republic of, 21431
        • Novo Nordisk Investigational Site
      • Seongnam-si, Korea, Republic of, 463-707
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 06273
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 02841
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 08308
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 05030
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 04763
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 06135
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 07061
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 6601
        • Novo Nordisk Investigational Site
      • Suwon, Korea, Republic of, 16499
        • Novo Nordisk Investigational Site
      • Yangsan, Korea, Republic of, 50612
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese patients and overweight patients with obesity-related comorbidities

Description

Inclusion Criteria: - The decision to initiate treatment with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician before and independently from the decision to include the patient in this study - 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 for the study - Male or Female of Native Korean, age greater than or equal to 18 years who is scheduled to start treatment with Saxenda® based on the clinical judgment of physician as specified in the Korean-Prescribing Information (local label) Exclusion Criteria: - Patients who are or have previously been on Saxenda® therapy - Known or suspected hypersensitivity to Saxenda® , the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Treatment with any investigational drug within 30 days prior to enrolment into the study - Female patient who is pregnant, breast-feeding, or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Overall Population
Patients will be treated with commercially available liraglutide 3.0 mg according to routine clinical practice at the discretion of the treating physician
Drug: Liraglutide
Patients will initiate treatment with liraglutide according to the approved label in Korea. Patients will initiate 0.6 mg daily and weekly increase the dose by 0.6 mg until reaching 3.0 mg daily. Patients will then continue to stay on 3.0 mg/day (total treatment duration: 26 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs) by preferred term (PT)
Time Frame: From baseline to week 13 (± 3 weeks)
Count of events
From baseline to week 13 (± 3 weeks)
Incidence of adverse events (AEs) by preferred term (PT)
Time Frame: From baseline to week 26 (± 3 weeks)
Count of events
From baseline to week 26 (± 3 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse drug reaction (ADRs)
Time Frame: From baseline to week 13 (± 3 weeks)
Count of events
From baseline to week 13 (± 3 weeks)
Number of adverse drug reaction (ADRs)
Time Frame: From baseline to week 26 (± 3 weeks)
Count of events
From baseline to week 26 (± 3 weeks)
Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)
Time Frame: From baseline to week 13 (± 3 weeks)
Count of events
From baseline to week 13 (± 3 weeks)
Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)
Time Frame: From baseline to week 26 (± 3 weeks)
Count of events
From baseline to week 26 (± 3 weeks)
Number of unexpected AEs and unexpected ADRs
Time Frame: From baseline to week 13 (± 3 weeks)
Count of events
From baseline to week 13 (± 3 weeks)
Number of unexpected AEs and unexpected ADRs
Time Frame: From baseline to week 26 (± 3 weeks)
Count of events
From baseline to week 26 (± 3 weeks)
Number of unexpected SAEs and unexpected SADRs
Time Frame: From baseline to week 13 (± 3 weeks)
Count of events
From baseline to week 13 (± 3 weeks)
Number of unexpected SAEs and unexpected SADRs
Time Frame: From baseline to week 26 (± 3 weeks)
Count of events
From baseline to week 26 (± 3 weeks)
Dose of liraglutide after administration initiation
Time Frame: week 13 (± 3 weeks)
Measured in mg
week 13 (± 3 weeks)
Dose of liraglutide after administration initiation
Time Frame: week 26 (± 3 weeks)
Measured in mg
week 26 (± 3 weeks)
Body weight loss (%) from week 0 to week 13
Time Frame: Week 0, week 13
Measured in percentage
Week 0, week 13
Body weight loss (%) from week 0 to week 26
Time Frame: Week 0, week 26
Measured in percentage
Week 0, week 26
Body weight loss (kg) from week 0 to week 13
Time Frame: Week 0, week 13
Measured in kg
Week 0, week 13
Body weight loss (kg) from week 0 to week 26
Time Frame: Week 0, week 26
Measured in kg
Week 0, week 26
The proportion of patients losing at least 5% of week 0 body weight at week 13
Time Frame: Week 0, week 13
Proportion of patients
Week 0, week 13
The proportion of patients losing at least 5% of week 0 body weight at week 26
Time Frame: Week 0, week 26
Proportion of patients
Week 0, week 26
The proportion of patients losing more than 10% of week 0 body weight at week 13
Time Frame: Week 0, week 13
Proportion of patients
Week 0, week 13
The proportion of patients losing more than 10% of week 0 body weight at week 26
Time Frame: Week 0, week 26
Proportion of patients
Week 0, week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2018

Primary Completion (ACTUAL)

December 2, 2020

Study Completion (ACTUAL)

December 2, 2020

Study Registration Dates

First Submitted

June 6, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (ACTUAL)

June 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8022-4380
  • U111-1199-8606 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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