NCT03560336|Completed

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.

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN8022-4380U111-1199-8606

Study Type

observational

Target

758

Locations

1 country

Sites

Timeline

RegisteredJun 2018

StartedJul 2018

CompletionDec 2020

Brief 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. The participation is expected to be approximately for 26 weeks.

Trial Health

On Track

Trial Health Score

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

Enrollment

758

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach

1 country

28 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

June 6, 2018

Completed

12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed

17 days until next milestone

Study Start

First participant enrolled

July 5, 2018

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed

Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

June 6, 2018

Last Update Submit

July 8, 2021

Conditions

Obesity Overweight

Outcome Measures

Primary Outcomes (2)

Incidence of adverse events (AEs) by preferred term (PT)
Count of events
From baseline to week 13 (± 3 weeks)
Incidence of adverse events (AEs) by preferred term (PT)
Count of events
From baseline to week 26 (± 3 weeks)

Secondary Outcomes (18)

Number of adverse drug reaction (ADRs)
From baseline to week 13 (± 3 weeks)
Number of adverse drug reaction (ADRs)
From baseline to week 26 (± 3 weeks)
Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)
From baseline to week 13 (± 3 weeks)
Number of serious adverse events (SAEs) and serious adverse drug reations (SADRs)
From baseline to week 26 (± 3 weeks)
Number of unexpected AEs and unexpected ADRs
From baseline to week 13 (± 3 weeks)
+13 more secondary outcomes

Study Arms (1)

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

Interventions

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).

Overall Population

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Obese patients and overweight patients with obesity-related comorbidities

Contact the study team to confirm eligibility.