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Completed

NCT Number: NCT06283641

Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.

This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.

The study will last for about 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

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhua Christian Hospital_Metabolic Dept., Changhua, Taiwan

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Who can participate

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

Inclusion criteria

  • Male or Female of Taiwanese patients, age above or equal to 12 years who are under Saxenda® treatment or are scheduled to treat with Saxenda® according to approved label in Taiwan based on the clinical judgment of their treating physician.
  • Patients should have baseline (pre-dosing) values, including body height, weight and initial dosage of Saxenda® .
  • The decision to initiate treatment or to have started with commercially available Saxenda® has been made by the patient/Legally Acceptable Representative (LAR) and the physician independently from the decision to join this study.
  • Informed consent obtained before collection of clinical data for this study. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

Exclusion criteria

  • 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 initiation of Saxenda® treatment.
  • Female patient who is pregnant, breast-feeding, or intends to become pregnant.
  • Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation

Treatment and study plan

liraglutide

Drug

Participants will be treated with commercially available Saxenda® according to routine clinical practice at the discretion of the treating physician, following approved label in Taiwan. The decision to initiate treatment with commercially available Saxenda® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

Other names: Saxenda®

Primary outcomes

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

    Time frame: From baseline (week 0) to week 26

    Percent(%)

Secondary outcomes

  1. Number of adverse drug reaction (ADRs)

    Time frame: From baseline (week 0) to week 26

    Number of events

  2. Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)

    Time frame: From baseline (week 0) to week 26

    Number of events

  3. Number of unexpected AEs and unexpected ADRs

    Time frame: From baseline (week 0) to week 26

    Number of events

  4. Number of unexpected SAEs and unexpected SADRs

    Time frame: From baseline (week 0) to week 26

    Number of events

  5. Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label

    Time frame: From baseline (week 0) to week 26

    Milligram(mg)

  6. Body weight loss Percent (%) (Adult)

    Time frame: From baseline (week 0) to week 13

    Percent (%)

  7. Body weight loss (%) (Adult)

    Time frame: From baseline (week 0) to week 26

    Percent (%)

  8. Body weight loss Kilogram(Kg) (Adult)

    Time frame: From baseline (week 0) to week 13

    Kilogram(Kg)

  9. Body weight loss (kg) (Adult)

    Time frame: From baseline (week 0) to week 26

    Kilogram(Kg)

  10. The proportion of adult subjects losing at least 5% of baseline body weight

    Time frame: At Week 13

    Percent (%)

  11. The proportion of adult subjects losing at least 5% of baseline body weight

    Time frame: At Week 26

    Percent (%)

  12. The proportion of adult subjects losing more than 10% of baseline body weight

    Time frame: At Week 13

    Percent (%)

  13. The proportion of adult subjects losing more than 10% of baseline body weight

    Time frame: At Week 26

    Percent (%)

  14. The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda®

    Time frame: At Week 26

    Percent (%)

  15. Change in body mass index (BMI) (kg/m^2) (Adolescent)

    Time frame: From baseline (week 0) to week 13

    Kilogram(Kg) divided by meters squared(m2)

  16. Change in body mass index (BMI) (kg/m^2) (Adolescent)

    Time frame: From baseline (week 0) to week 26

    Kilogram(Kg) divided by meters squared(m2)

  17. Change in body mass index (BMI) (%) (Adolescent)

    Time frame: From baseline (week 0) to week 13

    Percent (%)

  18. Change in body mass index (BMI) (%) (Adolescent)

    Time frame: From baseline (week 0) to week 26

    Percent (%)

  19. Change in body mass index standard deviation score (BMI SDS) (Adolescent)

    Time frame: From baseline (week 0) to week 13

    Change in body mass index standard deviation score (BMI SDS)

  20. Change in body mass index standard deviation score (BMI SDS) (Adolescent)

    Time frame: From baseline (week 0) to week 26

    Change in body mass index standard deviation(BMI SDS)

  21. Body weight loss (%) (Adolescent)

    Time frame: From baseline (week 0) to week 13

    Percent (%)

  22. Body weight loss (%) (Adolescent)

    Time frame: From baseline (week 0) to week 26

    Percent (%)

  23. Body weight loss (kg) (Adolescent)

    Time frame: From baseline (week 0) to week 13

    Kilogram(Kg)

  24. Body weight loss (kg) (Adolescent)

    Time frame: From baseline (week 0) to week 26

    Kilogram(Kg)

  25. The proportion of adolescent subjects losing at least 4% of baseline BMI

    Time frame: At Week 13

    Percent(%)

  26. The proportion of adolescent subjects losing at least 4% of baseline BMI

    Time frame: At Week 26

    Percent(%)

  27. The proportion of adolescent subjects losing at least 10% of baseline BMI

    Time frame: At Week 13

    Percent(%)

  28. The proportion of adolescent subjects losing at least 10% of baseline BMI

    Time frame: At Week 26

    Percent(%)

  29. The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda®

    Time frame: At Week 26

    Percent(%)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Multicentre, Single-arm, Non-interventional Regulatory Post- Marketing Surveillance (rPMS) Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Jan 9, 2026

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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