NCT00748605

Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet

A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0 or 1600 mg/Day of S-2367 Administered Orally Once Daily With an Initial 6-Week Low Calorie Diet in Obese Males and Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 842 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

1. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week low calorie diet (LCD) of 950 kcal/day with or without S-2367 followed by 54 weeks while on a 800 kcal deficit reduced calorie diet (RCD) compared with placebo in medically stable and otherwise healthy obese male and female subjects 2. To evaluate the safety and tolerability of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54 weeks on a RCD compared with placebo in medically stable and otherwise healthy obese male and female subjects 3. To evaluate the steady-state/trough pharmacokinetics of 1600 mg/day S-2367 administered orally once daily with the morning meal after a 6-week LCD with or without S-2367 followed by 54 weeks on a RCD in obese male and female subjects 4. To evaluate the weight loss effect of 1600 mg/day S-2367 administered orally once daily with the morning meal during an initial 6-week LCD compared with placebo in medically stable and otherwise healthy obese male and female subjects

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	S-2367 Placebo	Four placebo tablets (total dose = 0 mg/day S-2367) administered orally once daily with AM (ante meridiem) meal while on both LCD (low calorie diet for 6 weeks) and RCD (reduced calorie diet for 54 weeks) for a total of 60 weeks
DRUG	S-2367 1600 mg q.d. 54 Weeks	Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on RCD for a total of 54 weeks
DRUG	S-2367 1600 mg q.d. 60 weeks	Four 400 mg S- 2367 tablets (total dose = 1600 mg/day S-2367) administered orally once daily with AM meal while on both LCD and RCD for a total of 60 weeks
OTHER	LCD (low calorie diet)	A low calorie diet was utilized during the first 6 weeks of the study
OTHER	RCD (reduced calorie diet)	A reduced calorie diet was used during the last 54 weeks for the study

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-11-01
• Completion: 2009-01-01
• First posted: 2008-09-08
• Last updated: 2018-05-11

Locations

40 sites across 1 country: United States