A Weight Maintenance Study in Obese Patients

Official Title: “A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension”

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.

Intervention(s) in this Clinical Trial

• Drug: taranabant
  • taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
• Drug: Comparator: placebo
  • Placebo capsules once daily. Treatment for 52 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Arm 1: MK0364 Pbo capsules once daily
• Experimental: 2
  • Arm 2: MK0364 0.5 mg capsule once daily
• Experimental: 3
  • Arm 3: MK0364 1 mg capsule once daily
• Experimental: 4
  • Arm 4: MK0364 2 mg capsule once daily

Primary Measures

• Body weight at 52 weeks, safety and tolerability.
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Secondary Measures

• Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
• Patient is male or female >=18 and <= 65 years of age
• Patient understands the study procedures and alternative treatments available
• Patient is able to read, understand and complete study questionnaires

Exclusion Criteria:

• Patient has a history or presence of a major psychiatric disorder
• Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
• Patient has a history of seizures or is at high risk of developing seizures
• Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg
• Patient has diabetes mellitus as defined by medical history

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

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/NCT00420589

Study ID Number: 2006_512

ClinicalTrials.gov Identifier: NCT00420589

Health Authority: United States: Food and Drug Administration