A Study of the Safety of R256918 in Obese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01041677
First received: December 30, 2009
Last updated: January 15, 2013
Last verified: January 2013

December 30, 2009
January 15, 2013
February 2008
October 2008   (final data collection date for primary outcome measure)
Hepatic Triglyceride Content (HTGC) as measured by 1H-Magnetic Resonance Spectroscopy (MRS). [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
The primary outcome measured is the Hepatic Triglyceride Content (HTGC) as measured by 1H-Magnetic Resonance Spectroscopy (MRS). [ Time Frame: Baseline, 6 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01041677 on ClinicalTrials.gov Archive Site
  • Change in Body weight [ Time Frame: Baseline, weeks 1, 2, 4, 6, 8,10,12,14 ] [ Designated as safety issue: No ]
  • Change in alanine aminotransferase and aspartate aminotransferase [ Time Frame: Baseline, weeks 4, 6, 8,12,14 ] [ Designated as safety issue: Yes ]
  • Changes in fasting glucose and insulin [ Time Frame: Baseline, weeks 6, 12 ] [ Designated as safety issue: No ]
  • Changes in systolic and diastolic blood pressure [ Time Frame: Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14 ] [ Designated as safety issue: No ]
  • Changes in total-, HDL- and LDL-cholesterol and triglycerides [ Time Frame: Baseline, weeks 6,12 ] [ Designated as safety issue: Yes ]
  • Change in Body weight [ Time Frame: Baseline, weeks 1, 2, 4, 6, 8,10,12,14 ] [ Designated as safety issue: No ]
  • Clinical lab results [ Time Frame: Baseline, weeks 4, 6, 8,12,14 ] [ Designated as safety issue: Yes ]
  • Changes in ECGs [ Time Frame: Baseline, weeks 1, 6, 12,14 ] [ Designated as safety issue: Yes ]
  • Changes in Vital signs [ Time Frame: Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14 ] [ Designated as safety issue: Yes ]
  • Changes in Lipid metabolism parameters [ Time Frame: Baseline, weeks 6,12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of the Safety of R256918 in Obese Patients
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Nutritional and Metabolic Diseases
  • Metabolic Diseases
  • Nutrition Disorders
  • Overweight
  • Drug: R256918
    10 mg capsule twice daily
  • Drug: placebo
    placebo capsule twice daily
  • Drug: R256918
    15 mg capsule twice daily
  • Experimental: 001
    R256918 10 mg capsule twice daily
    Intervention: Drug: R256918
  • Experimental: 002
    R256918 15 mg capsule twice daily
    Intervention: Drug: R256918
  • Placebo Comparator: 003
    placebo placebo capsule twice daily
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Netherlands,   Sweden
 
NCT01041677
CR013735
Yes
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP