A Study of the Safety of R256918 in Obese Patients

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Criteria

Inclusion Criteria:

• Liver fat content (HTGC) between 3% and 15%

• Obese defined as BMI between 30 and 50 kg/square meter

• Fasting plasma glucose < 7.0 mmol/liter

Exclusion Criteria:

• History of Obesity with a known cause (eg. Cushings disease)

• Diabetes Mellitus

• Weight reducing diet or receiving drugs to treat obesity within 3 months prior to screening

• Significant change in smoking habits within 3 months before enrollment