A Study of the Safety of R256918 in Obese Patients

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT01041677

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

23.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Nutritional and Metabolic Diseases Metabolic Diseases Nutrition Disorders Overweight	Drug: R256918 Drug: placebo Drug: R256918	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-Center Study to Evaluate the Effect of JNJ-16269110 on Hepatic Triglyceride Content in Obese Subjects

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 R256918 10 mg capsule twice daily	Drug: R256918 10 mg capsule twice daily
Experimental: 002 R256918 15 mg capsule twice daily	Drug: R256918 15 mg capsule twice daily
Placebo Comparator: 003 placebo placebo capsule twice daily	Drug: placebo placebo capsule twice daily

Arm

Intervention/Treatment

Experimental: 001

R256918 10 mg capsule twice daily

Drug: R256918

10 mg capsule twice daily

Experimental: 002

R256918 15 mg capsule twice daily

Drug: R256918

15 mg capsule twice daily

Placebo Comparator: 003

placebo placebo capsule twice daily

Drug: placebo

placebo capsule twice daily

Outcome Measures

Primary Outcome Measures

Hepatic Triglyceride Content (HTGC) as measured by 1H-Magnetic Resonance Spectroscopy (MRS). [Baseline, 6 weeks, 12 weeks]

Secondary Outcome Measures

Change in Body weight [Baseline, weeks 1, 2, 4, 6, 8,10,12,14]
Change in alanine aminotransferase and aspartate aminotransferase [Baseline, weeks 4, 6, 8,12,14]
Changes in fasting glucose and insulin [Baseline, weeks 6, 12]
Changes in systolic and diastolic blood pressure [Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14]
Changes in total-, HDL- and LDL-cholesterol and triglycerides [Baseline, weeks 6,12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country
1	Helsinki	Finland
2	Zuidlaren	Netherlands
3	Göteborg	Sweden

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.