Belviq Tablet® Post Marketing Surveillance Protocol

Post-marketing surveillance of Lorcaserin

Study Overview

• Status: Unknown
• Conditions: Weight Loss

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 Type: Observational
• Enrollment (Anticipated): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

residents of Korea, in real-world practice

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse event after this drug administration in general medical	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.	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2015
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: ID-BVQ-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No