748605
Last Update Posted: 2018-05-11
Recruiting has ended
All Genders accepted | 18 Years-65 Years |
842 Estimated Participants | No Expanded Access |
Interventional Study | Accepts healthy volunteers |
Phase IIb One Year Efficacy and Safety Study of S-2367 in Obese Subjects With Initial 6-Week Low Calorie Diet
- 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
- 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
- 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
- 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
Eligibility
Relevant conditions:
Obesity
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov