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Completed

NCT Number: NCT03560336

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.

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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).

Primary outcomes

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

    Time frame: From baseline to week 13 (± 3 weeks)

    Count of events

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

    Time frame: From baseline to week 26 (± 3 weeks)

    Count of events

Secondary outcomes

  1. Number of adverse drug reaction (ADRs)

    Time frame: From baseline to week 13 (± 3 weeks)

    Count of events

  2. Number of adverse drug reaction (ADRs)

    Time frame: From baseline to week 26 (± 3 weeks)

    Count of events

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

    Time frame: From baseline to week 13 (± 3 weeks)

    Count of events

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

    Time frame: From baseline to week 26 (± 3 weeks)

    Count of events

  5. Number of unexpected AEs and unexpected ADRs

    Time frame: From baseline to week 13 (± 3 weeks)

    Count of events

  6. Number of unexpected AEs and unexpected ADRs

    Time frame: From baseline to week 26 (± 3 weeks)

    Count of events

  7. Number of unexpected SAEs and unexpected SADRs

    Time frame: From baseline to week 13 (± 3 weeks)

    Count of events

  8. Number of unexpected SAEs and unexpected SADRs

    Time frame: From baseline to week 26 (± 3 weeks)

    Count of events

  9. Dose of liraglutide after administration initiation

    Time frame: week 13 (± 3 weeks)

    Measured in mg

  10. Dose of liraglutide after administration initiation

    Time frame: week 26 (± 3 weeks)

    Measured in mg

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

    Time frame: Week 0, week 13

    Measured in percentage

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

    Time frame: Week 0, week 26

    Measured in percentage

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

    Time frame: Week 0, week 13

    Measured in kg

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

    Time frame: Week 0, week 26

    Measured in kg

  15. 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

  16. 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

  17. 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

  18. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2018
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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