A Two Year Study to Assess the Efficacy, Safety, and Tolerability of MK-0364 in Obese Patients - A Two Year Study of MK-0364 in Obese Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2400

Inclusion Criteria

Body mass index (BMI) between 30 kg/m2 and 43 kg/m2
Patient meets at least 1 of the following 4 criteria:
•Triglyceride levels = 150 mg/dL (1.69 mmol/L) but = 600 mg/dL (6.8 mmol/L)
•HDL-C levels < 40 mg/dL (1.03 mmol/L) in men and < 50 mg/dL (1.29 mmol/L) in women
•Seated systolic blood pressure = 130 mm Hg or seated diastolic blood pressure = 85 mm Hg
•Impaired fasting glucose (FPG = 100 mg/dL [5.5 mmol/L] and < 126 mg/dL [7.0 mmol/L])
Patient is = 18 years of age.
Patient is highly unlikely to conceive.
Patient is able to read and understands the study procedures and agrees to participate in the study by giving written informed consent.
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

•Patients with a history or presence of a major DSM-IV-TR psychiatric disorder.
•Patients with recent (within 6 months prior to screening) diagnosis/episode/ recurrence of stroke or neurological disorder.
•Patients with inadequately controlled hypertension.
•Patients with a history of seizures or is at high risk of developing seizures (e.g. those with history of brain tumors, severe head trauma, or intracranial hemorrhage).
•Patients with 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.
•Patients with any endocrinopathy, or patient has abnormal TSH at screening.
•Patients with marked hypertriglyceridemia (fasting triglycerides >600 mg/dL [6.8 mmol/L]).
•Patients with significant cardiovascular disease, active liver disease or a history of chronic liver disease, significant pulmonary disease, significant gastrointestinal disease, significant renal disease or a history of neoplastic disease.
•Patients who are HIV positive as determined by medical history.
•Patients who are pregnant or lactating woman, or plan to become pregnant.
•Patients who have undergone surgical treatment for obesity.
•Patients with clinically significant abnormalities of laboratory safety tests including :Serum creatinine >1.5 times Upper Limit of Normal (ULN) (>2.1 mg/dL), Serum ALT and/or AST >2 times the ULN(ALT >50 mU/mL; AST >44 mU/mL) and hemoglobin <12.5 gm/dL [7.76 mmol/L] in men and <11.0 gm/dL [6.83 mmol/L] in women.
•Patients with viral hepatitis (hepatitis B or C).
•Patient currently uses, or has used within 3 months prior to Visit 1 (Week-3), or plans to use, any prescription or nonprescription drugs, including over-the-counter or herbal preparations (e.g., St. John's Wort), that can alter body weight.
•Patient treated with fenfluramine, dexfenfluramine either alone or in combination with any other medication at any time.
•Patients who use or are likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP 3A4 or who consume more than 1 quart (four 8 oz. glasses) of grapefruit juice per day at any time during the study.
•Patients with a history of substance abuse within the past 5 years.
•Patients who smoke cigarettes or used nicotine-containing products
•Patients who participated in a weight loss program involving pharmacologic treatment or dietary intervention during the 3 months prior to study start or intend to be involved in any such effort.
•Patients with clinically significant abnormalities of prestudy electrocardiogram, including but not limited to, prolonged QTc.
*Patients with self-reported history of seizures or are at high risk of developing seizures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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