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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00622765
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
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.

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

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 : Interventional  (Clinical Trial)
Actual Enrollment : 321 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, Dose-Ranging Study to Investigate the Safety and Efficacy of JNJ-16269110 in Overweight and Obese Subjects
Study Start Date : November 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: 001
R256918 5 mg capsule twice daily
Drug: R256918
5 mg capsule twice daily

Experimental: 002
R256918 10 mg capsule twice daily
Drug: R256918
10 mg capsule twice daily

Experimental: 003
R256918 15 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

Primary Outcome Measures :
  1. Mean change in body weight from baseline to Week 12. [ Time Frame: Baseline, 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Quality of Life scores on questionnaires. [ Time Frame: 12 weeks ]
  3. Safety parameters monitored at each visit. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00622765

Edegem, Belgium
Liege, Belgium
Frederiksberg C N/A, Denmark
Hellerup N/A, Denmark
Vipperroed, Denmark
Helsinki, Finland
Kuopio, Finland
Berlin, Germany
Dresden, Germany
Heidelberg, Germany
Amsterdam, Netherlands
Hilversum, Netherlands
Rotterdam, Netherlands
Göteborg, Sweden
Huddinge, Sweden
United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Luton, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Identifier: NCT00622765     History of Changes
Other Study ID Numbers: CR011362
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: April 2014

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Obesity, Overweight, Body Weight, Body Size, Nutritional and Metabolic Diseases

Additional relevant MeSH terms:
Metabolic Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms