A Study of MK0364 in Obese Patients (0364-014)

Study Overview
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Brief Summary
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A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.

Official Title
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A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK0364) in Obese Patients Followed by a 1-Year Extension

Conditions
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Obesity

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) between 30-43 kg/m2 Exclusion Criteria: History of major psychiatric disorder History of seizures or at high risk of developing seizures Blood pressure greater than 160/100 Fasting blood glucose greater than 126 mg/dL Triglycerides greater than 600 mg/dL

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 Part B will remain in the same treatment arm they were assigned to in Part 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 4 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 2: MK0364 4 mg capsule once daily. | Drug: Comparator: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.<br>* Other names: MK0364;|
| Experimental: Phase A/B: Arm 3<br>Phase A: Arm 3: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 3: MK0364 Pbo capsule once daily. | Drug: Comparator: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.<br>* Other names: MK0364;Drug: Comparator: placebo<br>* Placebo capsule once daily . 52 week treatment period.<br>|
| Experimental: Phase A/B: Arm 4<br>Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 4: MK0364 2 mg capsule once daily. | Drug: Comparator: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 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. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 5: MK0364 4 mg capsule once daily. | Drug: Comparator: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.<br>* Other names: MK0364;|
| Experimental: Phase A/B: Arm 6<br>Phase A: Arm 6: MK0364 6 mg once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 6: MK0364 6 mg capsule once daily. | Drug: Comparator: taranabant<br>* taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 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; prevention of weight regain; safety and tolerability |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity |  | 2 Years |