Belviq Tablet® Post Marketing Surveillance Protocol

Weight Loss Clinical Trial

Official title:

Belviq Tablet® Post Marketing Surveillance Protocol

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03741010
• Other study ID #: ID-BVQ-401
• Status: Enrolling by invitation
• Start date: February 2, 2015
• Est. completion date: February 1, 2021

Study information

• Verified date: August 2018
• Source: IlDong Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-marketing surveillance of Lorcaserin

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Weight Loss

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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