Obesity MedDRA version: 8.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Product Name: Taranabant
Product Code: Taranabant
Pharmaceutical Form: Capsule*
INN or Proposed INN: Taranabant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5,
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has a body mass index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive and has maintained a stable weight (±3 kg) for at least 3 months prior to study start. 2. Patient is male or female and between the ages of 18 and 65, inclusive, on day of signing informed consent. 3. Patient loses at least 6% of initial body weight during the LCD period. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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). 2. Patient has a history of seizures or is at high risk of having seizures. 3. 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: 1. To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet (LCD)-induced weight loss. 2. To assess the safety and tolerability of taranabant. ;Primary end point(s): Body Weight;Secondary Objective: To assess the proportion of obese patients who maintain at least 75% of the weight loss that occurred in the LCD period. 2. To assess the proportion of obese patients who maintain the loss of at least 5% of their initial (Week -6) body weight. 3. To assess the effects of taranabant on waist circumference. 4. To assess the effects of taranabant on biochemical markers, including fasting plasma lipid profile, fasting plasma glucose, fasting insulin, and insulin sensitivity. 5. To assess the effects of taranabant on blood pressure. 6. To assess the effects of taranabant on quality-of-life and health economic patient-reported outcomes (PRO). | — |
Countries
Sweden
Outcome results
None listed