A Study of the Safety of R256918 in Obese Patients
Condition: Obesity; Nutritional and Metabolic Diseases; Metabolic Diseases; Nutrition Disorders; Overweight
MeSH terms: Overweight; Metabolic Diseases; Nutrition Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the safety of 12 weeks of treatment with R256918, in obese patients
      (JNJ-16269110 and R256918 are different names for the same molecule). The primary objective
      of the study is to investigate mean changes in Hepatic Triglyceride Content (HTGC), which is
      the fat content of the liver, from baseline to week 6 and 12 by 1H-Magnetic Resonance
      Spectroscopy (MRS), a specialized non invasive radiology test. Additional measures include
      body mass index (BMI), fasting glucose,lipid levels, and blood pressure. Safety assessments
      performed during the trial include laboratory tests, vital sign measurements, and adverse
      event reporting.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double-blind (neither physician nor
      patient knows the name of the assigned drug), placebo-controlled , parallel-group study with
      3 treatment arms, each consisting of 27 obese patients. The study will include 3 phases -
      pretreatment, double-blind and posttreatment . During the pretreatment phase patients undergo
      general screening assessments and if eligible, Magnetic Resonance Spectroscopy (MRS)
      screening will be performed. During the double-blind treatment phase patients will receive
      dietary counseling, study medication, have urine and blood laboratory tests, a follow up MRS
      examination and have regular clinic visits for symptoms assessment. The double blind
      treatment phase ends with an end-of-treatment or early withdrawal visit. A patient
      withdrawing from the study prior to the end of the 12 week treatment phase will attend an
      early withdrawal visit, which is the same as the end-of-treatment visit. This visit will
      include laboratory tests and a follow up MRS examination. Post-treatment: A follow-up
      evaluation will occur 14 days after the end of treatment. Study visits are scheduled to occur
      nearly every 14 days following the baseline visit in week 1. The total study duration is
      approximately 15 weeks. The study will include the following evaluations of safety and
      tolerability: mean percent change in liver fat content at week 6 and week 12 or at the end of
      the patients participation in the study, in case of early withdrawal. Safety evaluations for
      the study will include the monitoring of adverse events, clinical laboratory tests including
      pregnancy testing, electrocardiograms (ECGs), vital sign measurements (pulse and blood
      pressure), physical examination, and patient reported assessment of GI symptoms. Special
      clinical laboratory safety tests will assess blood clotting or coagulation status, essential
      fatty acid status, lipid-soluble vitamin status: vitamin A, vitamin D, vitamin E, vitamin K,
      vitamin A/total cholesterol ratio, vitamin E/total cholesterol ratio and liver function
      tests. 10 mg capsules, 15 mg capsules, or matching placebo capsules taken orally.
    

Intervention name(s): R256918; placebo; R256918
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg capsule twice daily; placebo capsule twice daily; 15 mg capsule twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Body Weight; Body Size; Nutritional and Metabolic Diseases