drugset / Trial / NCT00747929
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Velneperit | Small molecule | 800 mg | Oral |
| Subject | Velneperit | Small molecule | 1600 mg | Oral |