A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities. - A 1 YR STUDY OF MK-0364 IN OBESE/OVERWEIGHT PATIENTS

Phase 1

Conditions: Obesity
MedDRA version: 8.1 Level: LLT Classification code 10027966 Term: Morbid obesity

Registration Number: EUCTR2006-004534-32-CZ

Lead Sponsor: Merck & Co., Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

1. Men (minimum 25%; targeting 40%) and women with a body mass index (BMI) between 27 kg/m2 and 43 kg/m2, inclusive.
2. Patients must be = 18 years of age.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient has diabetes mellitus as defined by medical history, or a fasting blood glucose =126 mg/dL (7.0 mmol/L) or random blood glucose =200 mg/dL (11.1 mmol/L), or uses oral or injectable antihyperglycemic medications.
2. Patient has a history or presence of a major psychiatric disorder including, but not limited to schizophrenia or other psychotic disorders, major depression, bipolar disorder, generalized anxiety disorder, personality disorder or eating disorder (e.g. bulimia, anorexia disorder).
3. Patient has a history of seizures or is at high risk of developing seizures (e.g., those with history of brain tumors or severe head trauma or intracranial hemorrhage).
4. Patient currently uses or is likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP3A4, or currently uses or plans to use any medication in the medication exclusion list.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: In obese patients and in overweight patients with obesity-related co-morbidities, to assess the effects of MK-0364 after 1 year of treatment on:<br> 1. body weight;<br> 2. safety and tolerability during treatment.<br> ;Primary end point(s): Body weight.;<br> Secondary Objective: In obese patients and in overweight patients with obesity-related co-morbidities, to assess the effects of MK-0364 on:<br> 1.waist circumference at 1 year;<br> 2.percent body fat at 1 year;<br> 3.biochemical markers [triglycerides, HDL-C, LDL-C subclasses, non-HDL-C, LDL-C, total cholesterol, fasting insulin, insulin sensitivity, fasting plasma glucose (FPG), adiponectin and C-reactive protein (CRP)] at 1 year;<br> 4.blood pressure at 1 year;<br> 5.Patient-Reported Outcomes (PRO) at 1 year.<br>

Secondary Outcome Measures

Name	Time	Method

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