Conditions: Obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 343
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if LY377604 + sibutramine work better than LY377604 or sibutramine alone in the treatment of obesity.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None

Interventions: intervention 1: LY377604 intervention 2: Sibutramine intervention 3: Metoprolol intervention 4: Placebo sibutramine intervention 5: Placebo Metoprolol intervention 6: Placebo LY377604
Intervention descriptions: intervention 1: Given daily, orally for 24 weeks intervention 2: given daily, orally for 24 weeks intervention 3: given daily, orally for 24 weeks (100 mg for 1 week followed by 200 mg for 23 weeks. Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day). intervention 4: given daily, orally for 24 weeks intervention 5: given daily, orally for 26 weeks (24 weeks plus 2 weeks of taper) intervention 6: given daily, orally for 24 weeks

Protocol document: