MedPath

Lorcaserin

Generic Name
Lorcaserin
Drug Type
Small Molecule
Chemical Formula
C11H14ClN
CAS Number
616202-92-7
Unique Ingredient Identifier
637E494O0Z
Background

Lorcaserin (previously APD-356), a highly selective 5HT2C receptor agonist, is used for the treatment of obesity. It has been shown to reduce body weight and food intake in animal models of obesity, and it is thought that targeting the 5HT2C receptor may alter body weight by regulating satiety. Lorcaserin is marketed as a salt form called Belviq, which is lorcaserin hydrochloride.

In February 2020, the FDA issued a Drug Safety Communication requesting the manufacturer of Belviq (lorcaserin hydrochloride tablets, 10 mg) and Belviq XR (lorcaserin hydrochloride extended-release tablets, 20 mg) to voluntarily withdraw these products from the U.S. market, and the company has submitted a request to voluntarily withdraw the drug. This decision was based on the results of a clinical trial assessing the risk of heart-related problems that found that patients treated with lorcaserin may have a higher risk of cancer.

Indication

For the treatment of obesity, as an adjunct to a reduced-calorie diet and increased physical activity.

Associated Conditions
Obesity

Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management

Phase 3
Completed
Conditions
Overweight
Obese
Interventions
Device: LLLT
First Posted Date
2014-05-02
Last Posted Date
2016-11-22
Lead Sponsor
Mayo Clinic
Target Recruit Count
44
Registration Number
NCT02129608
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Single Dose Study to Determine the Safety, Tolerability, and Pharmacokinetic Properties of Lorcaserin Hydrochloride (BELVIQ) in Obese Adolescents From 12 to 17 Years of Age

Phase 1
Completed
Conditions
Pharmacokinetics in Obese Adolescents
Interventions
First Posted Date
2013-12-30
Last Posted Date
2019-09-17
Lead Sponsor
Eisai Inc.
Target Recruit Count
8
Registration Number
NCT02022956
Locations
🇺🇸

Worlwide Clinical Trials, San Antonio, Texas, United States

🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

Phase 4
Completed
Conditions
Overweight
Type 2 Diabetes
Cardiovascular Disease
High Cardiovascular Risk
Obesity
Interventions
First Posted Date
2013-12-24
Last Posted Date
2019-07-16
Lead Sponsor
Eisai Inc.
Target Recruit Count
14673
Registration Number
NCT02019264
Locations
🇺🇸

InterMed, PA, Portland, Maine, United States

🇺🇸

Interventional Cardiac Consultants, Trinity, Florida, United States

🇺🇸

Spectrum Clinical Research, Baltimore, Maryland, United States

and more 475 locations

A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults

First Posted Date
2013-11-19
Last Posted Date
2019-09-30
Lead Sponsor
Eisai Inc.
Target Recruit Count
344
Registration Number
NCT01987427
Locations
🇺🇸

Scripps Clinical Research Center, La Jolla, California, United States

🇺🇸

Radiant Research - Dallas, Dallas, Texas, United States

🇺🇸

National Clinical Research - Norfolk, Norfolk, Virginia, United States

and more 10 locations

Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study

Phase 4
Conditions
Weight Gain
Interventions
Behavioral: Intensive dietary counseling
First Posted Date
2013-10-14
Last Posted Date
2014-01-30
Lead Sponsor
Southern California Institute for Research and Education
Target Recruit Count
15
Registration Number
NCT01962402
Locations
🇺🇸

VA Long Beach, Long Beach, California, United States

Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users

Phase 1
Completed
Conditions
Healthy
Drug Abuse
Interventions
Drug: Placebo
Drug: Active Comparator #1
Drug: Active Comparator #2
Drug: Active Comparator #3
First Posted Date
2009-01-26
Last Posted Date
2019-09-12
Lead Sponsor
Eisai Inc.
Target Recruit Count
35
Registration Number
NCT00828659
Locations
🇨🇦

Kendle Early Phase, Toronto, Toronto, Ontario, Canada

To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake

Phase 1
Completed
Conditions
Obesity
Interventions
First Posted Date
2009-01-26
Last Posted Date
2019-09-12
Lead Sponsor
Eisai Inc.
Target Recruit Count
56
Registration Number
NCT00829140
Locations
🇺🇸

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States

Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment

Phase 1
Completed
Conditions
Renal Impairment
Interventions
First Posted Date
2009-01-26
Last Posted Date
2019-09-12
Lead Sponsor
Eisai Inc.
Target Recruit Count
40
Registration Number
NCT00828438
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

Pharmacokinetic Properties of Lorcaserin in the Fed and Fasted State

Phase 1
Completed
Conditions
Obesity
Interventions
First Posted Date
2009-01-26
Last Posted Date
2019-09-12
Lead Sponsor
Eisai Inc.
Target Recruit Count
24
Registration Number
NCT00828724
Locations
🇺🇸

CRI Worldwide, Willingboro, New Jersey, United States

Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
First Posted Date
2009-01-26
Last Posted Date
2019-09-12
Lead Sponsor
Eisai Inc.
Target Recruit Count
24
Registration Number
NCT00828932
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

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