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

April 24, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

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 (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 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.
321

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

  • Belgium
      • Edegem, Belgium
      • Liege, Belgium
  • Denmark
      • Frederiksberg C N/A, Denmark
      • Hellerup N/A, Denmark
      • Vipperroed, Denmark
  • Finland
      • Helsinki, Finland
      • Kuopio, Finland
  • Germany
      • Berlin, Germany
      • Dresden, Germany
      • Heidelberg, Germany
  • Netherlands
      • Amsterdam, Netherlands
      • Hilversum, Netherlands
      • Rotterdam, Netherlands
  • Sweden
      • Göteborg, Sweden
      • Huddinge, Sweden
  • United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Luton, United Kingdom

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:

  • Obese or overweight at screening defined as: BMI greater than or equal to 30 kg/m2 and <50 kg/m2 or BMI greater than or equal to 27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia. For patients receiving antihypertensive and/or hypolipidemic medications, these should have been at a stable dosage for at least 2 months before the start of the run-in period. Controlled hypertension is defined as a diastolic blood pressure <100 mmHg and a systolic blood pressure <160 mmHg, in the presence of antihypertensive drug treatment. For patients who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C greater than or equal to 3.4 mmol/L (130 mg/dL), HDL C <1 mmol/L (40 mg/dL) for men or <1.3 mmol/L (50 mg/dL) for women, or triglycerides greater than or equal to 1.7 mmol/L (150 mg/dL)
  • A stable weight, i.e., increasing or decreasing not more than 5 kg in the 3 months before the start of the run-in period
  • Consumption of breakfast and dinner on a daily basis
  • Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with water, as judged by e.g., the patients's history of having no difficulty with swallowing e.g., capsules or intact tablets
  • Fasting plasma glucose <7.0 mmol/L (126 mg/dL) at screening
  • Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control

Exclusion Criteria:

  • History of obesity with a known cause (e.g., Cushing's disease)
  • History of anorexia nervosa, bulimia, or binge-eating disorder
  • An established diagnosis of diabetes mellitus or treatment with glucose lowering prescription drugs at screening
  • Prior exposure or known contraindication or hypersensitivity to R256918
  • History of weight-reducing diet or receiving any drugs to treat obesity within the 3 months prior to screening
  • Treatment with any investigational drug or device within 1 month before the start of the run-in period
  • History or evidence of liver or renal impairment
  • History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology
  • History of clinically significant gastro-intestinal disease
  • History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy
  • Previous gastric restrictive surgery or other surgical procedures to induce weight loss
  • Liposuction within the last 3 months before screening
  • Pregnant or nursing women, or women who plan to become pregnant during the study
  • History of significant cardiovascular disease or hypertension
  • Elevated levels of thyroid-stimulating hormone (TSH)
  • A significant change in smoking habits within 3 months of the start of the run-in period
  • Malignancy or a history of a malignancy within 5 years before the start of the run-in period, other than basal cell carcinomas of the skin or in situ cervical carcinoma
  • History of seizures or significant central nervous system-related disorders
  • History of significant psychiatric disorder, including, schizophrenia, or psychosis

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
  • 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 5 mg capsule twice daily
Drug: R256918
5 mg capsule twice daily
Drug: R256918
10 mg capsule twice daily
Drug: R256918
15 mg capsule twice daily
EXPERIMENTAL: 002
R256918 10 mg capsule twice daily
Drug: R256918
5 mg capsule twice daily
Drug: R256918
10 mg capsule twice daily
Drug: R256918
15 mg capsule twice daily
EXPERIMENTAL: 003
R256918 15 mg capsule twice daily
Drug: R256918
5 mg capsule twice daily
Drug: R256918
10 mg capsule twice daily
Drug: R256918
15 mg capsule twice daily
PLACEBO_COMPARATOR: 004
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
Mean change in body weight from baseline to Week 12.
Time Frame: Baseline, 12 weeks
Baseline, 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
Changes in body weight, body mass index (BMI), body composition, blood pressure, glucose, intestinal hormone levels, beta cell function and lipid parameters.
Time Frame: 12 weeks
12 weeks
Quality of Life scores on questionnaires.
Time Frame: 12 weeks
12 weeks
Safety parameters monitored at each visit.
Time Frame: 12 weeks
12 weeks

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.
November 1, 2007

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.
June 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.
June 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 21, 2007

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.
February 14, 2008

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.
February 25, 2008

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.
May 13, 2014

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.
April 24, 2014

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.
April 1, 2014

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.
  • CR011362
  • R256918OBE2001

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings