NCT00747929

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

A Double-Blind, Multi-Center, Randomized, Parallel-Group, Yearlong Study to Assess the Efficacy and Safety of 0, 800, or 1600 mg/Day of S-2367 Administered Orally Once Daily With a Reduced Calorie Diet in Obese Males and Females

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 724 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	S-2367 Placebo	four placebo tablets (total dose = 0 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks,
DRUG	S-2367 800 mg	two 400 mg S-2367 tablets (total dose = 800 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for a total of 54 weeks
DRUG	S-2367 1600 mg	four 400 mg S-2367 tablets (total dose = 1600 mg/day S-2367) administered orally once-a-day with morning meal while on a reduced calorie diet for total of 54 weeks,
OTHER	Reduced Calorie Diet	A diet with restricted calorie content

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

38 sites across 1 country: United States