A Study of MK0364 in Obese Patients

Official Title: “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”

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

Intervention(s) in this Clinical Trial

• Drug: Comparator: taranabant
  • taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
• Drug: Comparator: placebo
  • Placebo capsule once daily . 52 week treatment period.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Phase A/B; Arm 1
  • 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.
• Experimental: Phase A/B: Arm 2
  • 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.
• Experimental: Phase A/B: Arm 3
  • 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.
• Experimental: Phase A/B: Arm 4
  • 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.
• Experimental: Phase A/B: Arm 5
  • 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.
• Experimental: Phase A/B: Arm 6
  • 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.

Primary Measures

• Decreases body weight; prevention of weight regain; safety and tolerability
  • Time Frame: 2 Years
    Safety Issue?: Yes

Secondary Measures

• 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
  • Time Frame: 2 Years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00131391

Study ID Number: 2005_034

ClinicalTrials.gov Identifier: NCT00131391

Health Authority: United States: Food and Drug Administration