A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and 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 effectiveness and safety of 12 weeks of treatment with
      JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of
      effectiveness is the change in body weight at a clinically relevant dosage level during
      treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry
      which is a specialized x-ray test that measures body composition), 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 (assigned study drug by chance), double-blind (both the patient and
      investigator do not know whether patient is assigned to receive study drug or placebo),
      placebo-controlled study involving overweight and obese patients. Patients are randomized to
      one of 4 treatment groups and receive study drug or placebo for a period of 12 weeks. The
      study consists of 3 phases: a pretreatment phase (including a screening period of 1 week and
      a period prior to active treatment of 4 weeks), the treatment period of 12 weeks, and a
      posttreatment phase (consisting of a follow-up visit). Standardized nonpharmacologic therapy
      (individualized calorie deficit diets containing no more than 30% calories from fat and
      nutritional counseling) will be administered from Week 4 through the follow-up period. During
      the treatment period, patients visit the center every two weeks. On each visit, patients come
      to the clinic after 8 hours fasting. For effectiveness assessments, patients will be weighed
      and BMI calculated at each visit; waist and hip circumference and DEXA measurements (for body
      composition and fat mass analysis) will be performed at selected time points. Additional
      effectiveness assessments from a blood sample include levels of fasting hemoglobin type A1c
      (HbA1c), glucose, cholesterol, triglycerides, insulin, C-peptide, and gastrointestinal
      hormones. Insulin sensitivity and pancreas function are evaluated. Safety evaluations,
      including incidence of adverse events, clinical laboratory results, vital signs, and
      electrocardiograms, are performed during the study. Patients complete a questionnaire related
      to stomach/bowel symptoms (GI) throughout the study. Blood samples will also be drawn for an
      analysis of the subjects genes and an analyses of the body's handling of the study drug. The
      overall duration of the study for each patient is approximately 19 weeks. The study
      hypothesis is that treatment with JNJ-16269110 (R256918) will cause a change in body weight
      compared to placebo and will be well tolerated in overweight and obese patients. This
      hypothesis will be investigated at each dosage level to determine a clinically relevant dose.
      5 mg capsules, 10 mg capsules, 15 mg capsules, or matching placebo capsules taken orally.
    

Intervention name(s): placebo; R256918; R256918; R256918
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo capsule twice daily; 5 mg capsule twice daily; 10 mg 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