Obesity MedDRA version: 7.1 Level: LLT Classification code 10029883
Conditions
Interventions
Product Name: MK-0364
Product Code: MK-0364
Pharmaceutical Form: Capsule*
INN or Proposed INN: N/A
CAS Number: N/A
Curre
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In obese patients, (1) to assess the effects of 2 or 4 mg MK-0364 after 1 year of treatment on body weight; (2) to assess the safety and tolerability of MK-0364 during treatment. ; Secondary Objective: In obese patients, to assess the effects of 2 or 4mg MK-0364 on: 1. body weight after 2 years of treatment; 2. waist circumference at 1 year and 2 years; 3. percent body fat at 6 months; 4. biochemical markers [triglycerides, HDL-C, non-HDL-C, LDL-C, total cholesterol, fasting insulin, insulin sensitivity, fasting plasma glucose (FPG), ] at 1 year; 5. proportion of patients with metabolic syndrome after 1 year and 2 years of treatment; 6. blood pressure at 1 year; 7. Patient-Reported Outcomes (PRO) at 1 year; 8. body weight after 52 weeks of treatment after the dose change; 9. After treatment with MK-0364 6 mg, to assess the effect of treatment with MK-0364 2 mg, relative to placebo, on (a) body weight; (b) waist circumference; (c) metabolic syndrome; (d) biochemical markers (triglycerides, HDL-C, non-HDL-C, LDL-C, total cholesterol, fasting insulin, insulin sensitivity and fasting plasma glucose). ;Primary end point(s): The primary efficacy variable is body weight. The primary efficacy variable of body weight consists of 3 endpoints: change from baseline at Week 52, proportion of patients who lose =5% of their baseline body weight (5% responders) and proportion of patients who lose =10% of their baseline body weight (10% responders) at Week 52. | — |
Countries
Austria, Czech Republic, Denmark, Finland, Germany, Norway, Spain
Outcome results
None listed