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ObesityNCT03560336

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.

An observational study of Obesity and Overweight, run by Novo Nordisk A/S at 28 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
Liraglutide
How many people
758 participants
Where
28 sitesSouth Korea
Study dates
5 Jul 2018to 2 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Obese patients and overweight patients with obesity-related comorbidities

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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

South Korea28 sites

  • Novo Nordisk Investigational Site

    Busan, 47360

  • Novo Nordisk Investigational Site

    Busan, 47392

  • Novo Nordisk Investigational Site

    Busan, 48107

  • Novo Nordisk Investigational Site

    Busan, 49201

  • Novo Nordisk Investigational Site

    Busan, 49267

  • Novo Nordisk Investigational Site

    Busan

  • Novo Nordisk Investigational Site

    Daegu, 42601

  • Novo Nordisk Investigational Site

    Daejeon, 302-718

  • Novo Nordisk Investigational Site

    Daejeon, 361-711

  • Novo Nordisk Investigational Site

    Gangwon-do, 26426

  • Novo Nordisk Investigational Site

    Gwangju, 12756

  • Novo Nordisk Investigational Site

    Gyeonggi-do, 10475

  • Novo Nordisk Investigational Site

    Gyeonggi-do, 13120

  • Novo Nordisk Investigational Site

    Gyeonggi-do, 15355

  • Novo Nordisk Investigational Site

    Gyeonggi-do

  • Novo Nordisk Investigational Site

    Incheon, 21431

  • Novo Nordisk Investigational Site

    Seongnam-si, 463-707

  • Novo Nordisk Investigational Site

    Seoul, 02841

  • Novo Nordisk Investigational Site

    Seoul, 04763

  • Novo Nordisk Investigational Site

    Seoul, 05030

  • Novo Nordisk Investigational Site

    Seoul, 06135

  • Novo Nordisk Investigational Site

    Seoul, 06273

  • Novo Nordisk Investigational Site

    Seoul, 07061

  • Novo Nordisk Investigational Site

    Seoul, 08308

  • Novo Nordisk Investigational Site

    Seoul, 6601

  • Novo Nordisk Investigational Site

    Seoul

  • Novo Nordisk Investigational Site

    Suwon, 16499

  • Novo Nordisk Investigational Site

    Yangsan, 50612

Other trials in South Korea

About this study

Official title: 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.

Conditions
Obesity, Overweight
Being tested
Liraglutide
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    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).

Study groups in NCT03560336
Study groupRoleWhat they receive
Overall PopulationPatients will be treated with commercially available liraglutide 3.0 mg according to routine clinical practice at the discretion of the treating physician
Receives: Drug: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs) by preferred term (PT)

    Count of events

    Measured: From baseline to week 13 (± 3 weeks)

  2. Incidence of adverse events (AEs) by preferred term (PT)

    Count of events

    Measured: From baseline to week 26 (± 3 weeks)

Secondary outcomes (18)

  1. Number of adverse drug reaction (ADRs)

    Count of events

    Measured: From baseline to week 13 (± 3 weeks)

  2. Number of adverse drug reaction (ADRs)

    Count of events

    Measured: From baseline to week 26 (± 3 weeks)

  3. Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)

    Count of events

    Measured: From baseline to week 13 (± 3 weeks)

  4. Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)

    Count of events

    Measured: From baseline to week 26 (± 3 weeks)

  5. Number of unexpected AEs and unexpected ADRs

    Count of events

    Measured: From baseline to week 13 (± 3 weeks)

  6. Number of unexpected AEs and unexpected ADRs

    Count of events

    Measured: From baseline to week 26 (± 3 weeks)

  7. Number of unexpected SAEs and unexpected SADRs

    Count of events

    Measured: From baseline to week 13 (± 3 weeks)

  8. Number of unexpected SAEs and unexpected SADRs

    Count of events

    Measured: From baseline to week 26 (± 3 weeks)

  9. Dose of liraglutide after administration initiation

    Measured in mg

    Measured: week 13 (± 3 weeks)

  10. Dose of liraglutide after administration initiation

    Measured in mg

    Measured: week 26 (± 3 weeks)

  11. Body weight loss (%) from week 0 to week 13

    Measured in percentage

    Measured: Week 0, week 13

  12. Body weight loss (%) from week 0 to week 26

    Measured in percentage

    Measured: Week 0, week 26

  13. Body weight loss (kg) from week 0 to week 13

    Measured in kg

    Measured: Week 0, week 13

  14. Body weight loss (kg) from week 0 to week 26

    Measured in kg

    Measured: Week 0, week 26

  15. The proportion of patients losing at least 5% of week 0 body weight at week 13

    Proportion of patients

    Measured: Week 0, week 13

  16. The proportion of patients losing at least 5% of week 0 body weight at week 26

    Proportion of patients

    Measured: Week 0, week 26

  17. The proportion of patients losing more than 10% of week 0 body weight at week 13

    Proportion of patients

    Measured: Week 0, week 13

  18. The proportion of patients losing more than 10% of week 0 body weight at week 26

    Proportion of patients

    Measured: Week 0, week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start5 Jul 2018
  3. Primary completion2 Dec 2020
  4. Study completion2 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
758 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03560336
Sponsor's protocol ID
NN8022-4380
Other IDs
U111-1199-8606
Status last verified
Jul 2021
First submitted
6 Jun 2018
Last updated
9 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Overweight, run by Novo Nordisk A/S at 28 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) by preferred term (PT) (time frame: From baseline to week 13 (± 3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03560336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.

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