Obesity MedDRA version: 8.1 Level: LLT Classification code 10027966 Term: Morbid obesity
Conditions
Interventions
Product Name: MK-0364
Product Code: MK-0364
Pharmaceutical Form: Capsule*
INN or Proposed INN: MK-0364
Concentration unit: mg milligram(
Sponsors
Suomen MSD Oy
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 1. body weight; 2. safety and tolerability during treatment. ; Secondary Objective: In obese patients and in overweight patients with obesity-related co-morbidities, to assess the effects of MK-0364 on: 1. waist circumference at 1 year; 2. percent body fat at 1 year; 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; 4. blood pressure at 1 year; 5. Patient-Reported Outcomes (PRO) at 1 year. ;Primary end point(s): Body weight. | — |
Countries
Austria, Czech Republic, Denmark, Finland, France, Germany, Sweden
Outcome results
None listed