Title
Efficacy and Safety of THR-4109 in Obese Subjects
A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of THR-4109 in Obese Subjects
The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.
THR-4109 maximum dose in study is 115 mg via oral capsule daily in a.m. and 115 mg via oral capsule daily in p.m. for 24 weeks
Oral capsules daily in a.m. and in p.m. for 24 weeks
Inclusion Criteria: 30 to 60 years of age Body mass index between 30 and 40 kg/m2 Women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study Able and willing to give written informed consent Exclusion Criteria: Weight loss of more than 3 kg in the previous 3 months Current or previous use (within 3 months) of medications that influence weight Known endocrine origin for obesity, such as hypothyroidism and Cushing's syndrome Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse Current serious/unstable medical condition Current pharmacologically treated diabetes or fasting plasma glucose ≥ 126 mg/dL
