Safety and Efficacy of APD356 in the Treatment of Obesity

Phase 2 Completed 400 enrolled Eisai Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity. The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy. Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify.

Timeline

Start: 2005-06
Primary completion: —
Completion: 2005-11

Outcome

Met primary endpoint

paper compared to placebo weight loss of 0.3 kg (P < 0.001 for each group). PMID 19057523 ↗

Publications

Smith SR, Prosser WA, Donahue DJ, Morgan ME, Anderson CM, Shanahan WR; APD356-004 Study Group. Lorcaserin (APD356), a selective 5-HT(2C) agonist, reduces body weight in obese men and women. Obesity (Silver Spring). 2009 Mar;17(3):494-503. doi: 10.1038/oby.2008.537. Epub 2008 Dec 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorcaserin	Small molecule	10 mg	—
Subject	Lorcaserin	Small molecule	15 mg	—