Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Reduced Calorie Diet
Completed
Shionogi
Phase 2
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
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet
Completed
Shionogi
Phase 2
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
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