Obesity MedDRA version: 7.1 Level: LLT Classification code 10029883
Conditions
Interventions
Product Name: Taranabant
Product Code: Taranabant
Pharmaceutical Form: Capsule*
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: Taranabant
Other descriptive name: N/A
Concentration unit
Sponsors
Merck Sharp & Dohme (Sweden) AB
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. • 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). • Patients currently uses, or has used within 3 months prior to Visit 1 (Week-3), or plans to use, any prescription or nonprescrition 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 |
|---|---|
| Secondary Objective: In obese pts: 1. To assess effect of 52 wks trt with taranabant (MK364) 4 mg, relative to plbo, on: a) waist circumference (WC); b) metabolic syndrome (MS); c) biochemical markers (triglycerides, HDL-C, non-HDL-C, LDL-C, total cholesterol, fasting insulin, fasting plasma glucose, and insulin sensitivity); d) blood pressure (BP); e) patient reported outcomes (PRO) 2. After trt with MK364 6 mg, assess effect of 52 wks of trt with MK364 2 mg, relative to pbo, on: a) WC; b) MS; c) biochemical markers; d) BP; (e) PRO 3. In pts who complete 52 wks of trt on pbo or MK364 4 mg, assess the effect of 52 additional wks of trt with MK364 4 mg, relative to pbo, on: a) body weight; b) WC; c) MS; d) biochemical markers; e) BP; f) PRO 4. In pts who experienced weight loss on MK364 6 mg, to assess effects of MK364 2 mg after 52 wks on: a) proportion who maintain the loss of =5% of their initial body weight; b) proportion who maintain =75% of the weight loss induced by MK364 6 mg ;Primary end point(s): The primary efficacy variables are body weight at Week 52. 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. ;Main Objective: In obese patients: 1) Safety and tolerability during treatment. 2) To assess the effect of 52 wks of treatment with taranabant 4 mg, relative to placebo, on body weight. 3) After treatment with taranabant 6 mg, to assess the effect of 52 weeks of treatment with taranabant 2 mg on prevention of weight regain, relative to placebo | — |
Countries
Hungary, Ireland, Italy, Sweden, United Kingdom
Outcome results
None listed