A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)

Study Overview
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Brief Summary
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A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.

Official Title
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A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension

Conditions
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Obesity

Intervention / Treatment
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* Drug: taranabant
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese patients with a body mass index between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia, and sleep apnea Exclusion Criteria: Patients with serious or unstable current or past medical conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Phase A/B: Arm 1<br>Phase A: Arm 1: MK0364 Pbo capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 1: MK0364 Pbo capsule once daily. | Drug: Comparator: Placebo<br>* Placebo capsule once daily. 52 week treatment period.<br>|
| Experimental: Phase A/B: Arm 2<br>Phase A: Arm 2: MK0364 2 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily. | Drug: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.<br>* Other names: MK0364;|
| Experimental: Phase A/B: Arm 3<br>Phase A: Arm 3: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3: MK0364 4 mg capsule once daily. | Drug: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.<br>* Other names: MK0364;|
| Experimental: Phase A/B: Arm 4<br>Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4: MK0364 6 mg capsule once daily. | Drug: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.<br>* Other names: MK0364;|
| Experimental: Phase A/B: Arm 5<br>Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily. | Drug: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 52 week treatment period.<br>* Other names: MK0364;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreases body weight; safety and tolerability |  | 156 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity |  | 156 Weeks |