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

Summary

APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults. Approximately 225 subjects will be randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15 mg once daily (QD), or lorcaserin alone.

Timeline

Start

2013-10-30

Primary completion

2014-08

Completion

2014-09-03

Publications

• Rebello CJ, Nikonova EV, Zhou S, Aronne LJ, Fujioka K, Garvey WT, Smith SR, Coulter AA, Greenway FL. Effect of Lorcaserin Alone and in Combination with Phentermine on Food Cravings After 12-Week Treatment: A Randomized Substudy. Obesity (Silver Spring). 2018 Feb;26(2):332-339. doi: 10.1002/oby.22094.
• Smith SR, Garvey WT, Greenway FL, Zhou S, Fain R, Pilson R, Fujioka K, Aronne LJ. Coadministration of lorcaserin and phentermine for weight management: A 12-week, randomized, pilot safety study. Obesity (Silver Spring). 2017 May;25(5):857-865. doi: 10.1002/oby.21811.

Drugs

Indications

No indication recorded.