Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess Short-term Safety and Tolerability of Lorcaserin + Two Doses of Immediate-Release Phentermine-HCl Compared w/ Lorcaserin Alone in Overweight & Obese Adults
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women who are obese or overweight. The study is evaluating the combination of two drugs for weight reduction. The drugs are called Belviq (also called lorcaserin HCL) and phentermine hydrochloride (phentermine HCL). The purpose of the study is to determine the safety and effectiveness of Belviq in combination with two different doses of phentermine HCL.
Belviq is a tablet and is FDA-approved as an addition to a reduced-calorie diet and exercise for chronic weight management. Phentermine HCL is a capsule and is FDA-approved for short-term addition in a weight reduction plan. The combination of the drugs, however, is not approved and is therefore considered experimental.
Study participants will be randomly assigned to one of three treatment arms:
· Arm A: Belviq + Phentermine Placebo
o Belviq twice daily + Phentermine placebo twice daily
· Arm B: Belviq + Phentermine–HCL + Phentermine placebo
o Belviq twice daily + Phentermine-HCL once daily + Phentermine placebo once daily
· Arm C: Belviq + Phentermine-HCL
o Belviq twice daily + Phentermine-HCL twice daily
A placebo is a blank capsule that looks like phentermine but contains no medicine. Neither participants nor the study physician and staff will know whether they are receiving active drug phentermine or placebo. All study participants will receive Belviq. Participants will receive diet and exercise counseling at 6 study visits.
Participants will be on study treatment for 12 weeks and have a follow-up visit 4 weeks after stopping treatment.
Disease Status and/or Stage
Weight Loss/Obesity
Sponsor
Eisai Inc.
Key Eligibility
- Men and women age 18 to 60
- Obese or overweight, Body Mass Index 27 or higher
- Detailed eligibility reviewed when you contact the study team
- Research Department, Center for Weight Management & Metabolic Clinical Research
- (646) 962-2424
- [email protected]
Principal Investigator
Louis J. Aronne, M.D
Contact
Protocol ID
WCMC IRB # 1310014369; Eisai Protocol # APD356-A001-402
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
[email protected]
