A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese Patients

Obesity Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Investigate the Safety and Efficacy of JNJ-16269110 in Overweight and Obese Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutrition Disorders
• Nutritional and Metabolic Diseases
• Obesity
• Overweight

• NCT number: NCT00622765
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Completion date: June 2008