Belviq Tablet® Post Marketing Surveillance Protocol

• Conditions: Weight Loss

• Registration Number: NCT03741010
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

Brief Summary

Post-marketing surveillance of Lorcaserin

Detailed Description

Lorcaserin(Belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. Lorcaserin was approved in 2015 the Republic of Korea for weigh loss in those who are obese. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.

Study Timeline

• Study Start: 2015-02-02
• Status Verified: 2018-08
• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Last Update Submitted: 2018-11-22
• Last Update Posted: 2018-11-26
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected.

1. Obese patients whose body mass index (BMI) is ≧30 kg/m2.
2. Overweight patients whose body mass index(BMI) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type II diabetes mellitus)

Exclusion Criteria

1. Patients with a hypersensitivity reaction to the drug or the ingredient of the drug
2. Female patients of childbearing potential and pregnant or lactating women
3. Patients taking another weight control drug
4. Patients with the medical history of drug abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse event after this drug administration in general medical	12 weeks	Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period.; Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.

Secondary Outcome Measures

Name	Time	Method
The change from baseline to week 12 in the Body Mass Index(BMI)	12 weeks	BMI is measured before administration of the drug and within 12 weeks after administration.