A Study of the Safety of R256918 in Obese Patients

January 15, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 001
R256918 10 mg capsule twice daily
Drug: R256918
10 mg capsule twice daily
Drug: R256918
15 mg capsule twice daily
Experimental: 002
R256918 15 mg capsule twice daily
Drug: R256918
10 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hepatic Triglyceride Content (HTGC) as measured by 1H-Magnetic Resonance Spectroscopy (MRS).
Time Frame: Baseline, 6 weeks, 12 weeks
Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Body weight
Time Frame: Baseline, weeks 1, 2, 4, 6, 8,10,12,14
Baseline, weeks 1, 2, 4, 6, 8,10,12,14
Change in alanine aminotransferase and aspartate aminotransferase
Time Frame: Baseline, weeks 4, 6, 8,12,14
Baseline, weeks 4, 6, 8,12,14
Changes in fasting glucose and insulin
Time Frame: Baseline, weeks 6, 12
Baseline, weeks 6, 12
Changes in systolic and diastolic blood pressure
Time Frame: Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14
Baseline, weeks 1, 2, 4, 6, 8, 10, 12, 14
Changes in total-, HDL- and LDL-cholesterol and triglycerides
Time Frame: Baseline, weeks 6,12
Baseline, weeks 6,12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR013735

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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