drugset / Trial / NCT00747929

Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet

NCT00747929

Phase 2 Completed 724 enrolled Shionogi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

1. To evaluate the effect of S-2367 on body weight when administered following a 6-week placebo lead-in period and then a 54-week 800 kilocalorie deficit reduced calorie diet compared to placebo in healthy obese male and female subjects 2. To evaluate the safety and tolerability of S-2367 during 54 weeks of drug exposure 3. To evaluate the steady-state/trough pharmacokinetics of S-2367

Timeline

Start
2007-06
Primary completion
2008-11
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Velneperit Small molecule 800 mg Oral
Subject Velneperit Small molecule 1600 mg Oral

Indications