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.

Sponsor
Novo Nordisk A/S
Study ID
NCT03560336
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Jul 5, 2018
Status verified
Jul 2021
Primary completion
Dec 2, 2020
Completion
Dec 2, 2020

Study Design

Enrollment
758 participants (actual)

Arms

  • Arm: 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

Primary Outcome Measure

Incidence of adverse events (AEs) by preferred term (PT) [ Time Frame: From baseline to week 13 (± 3 weeks) ]

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