Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study, conducted academic Pilot research purposes, this is not clear as
      to permit. when orlistat to sibutramine merge if there are additional effects of BMI and
      group, which has an attribute that is greater for the combined effect is to analyze.

        -  Study phase: Investigator-initiated clinical study (Pilot study)

        -  Method of blinding: Double-blind

        -  Control: Placebo-controlled

        -  Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and
           Sibutramine combination group = 1 : 1)

        -  Studied disease: Obesity

        -  Study population: Subjects eligible for inclusion/exclusion criteria

        -  Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and
           post-dosing observation period (4 weeks)
    

Detailed description: 
      After the screening period, patients eligible for inclusion/exclusion criteria would
      administer Sibutramine placebo and Orlistat placebo during 2 weeks of the run-in period,
      Subsequently, subjects are randomized to 2 groups of the Sibutramine monotherapy group and
      the Orlistat and Sibutramine combination group. Sibutramine monotherapy group would receive
      Sibutramine 10mg once daily and Orlistat placebo three times daily for 12 weeks; the Orlistat
      and Sibutramine combination group would receive Sibutramine 10mg once daily and Orlistat
      120mg three times daily for 12 weeks. After completing the dosing period, the occurrence of
      adverse events would be checked for 4 weeks and the study would be completed.

      Body weight, abdominal CT(Computed Tomography)(visceral fat examination), body fat analysis,
      etc. would be measured before the study initiation and after 14 weeks of treatment, and
      comparatively analyzed. A two sample t-test is conducted for the inter-group comparison and a
      paired t-rest is conducted for the comparison between baseline and after 14 weeks after the
      study initiation.
    

Intervention name(s): Sibutramine; Orlistat
Intervention type(s): Drug; Drug
Intervention description(s): ○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.
Treatment period: The total dosing period is 12 weeks.
Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily; ○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.
Treatment period: The total dosing period is 12 weeks.
Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily
Intervention MeSH terms: Orlistat; Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: obesity