Efficacy and Safety of THR-4109 in Obese Subjects

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theracos
• Collaborator: TFS Trial Form Support

Criteria

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