A Study of the Safety of R256918 in Obese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00622765

Obesity Nutritional and Metabolic Diseases Metabolic Diseases +2 more

COMPLETED PHASE2

Study to Evaluate HM15275 in Obese or Overweight Subjects Without Diabetes Mellitus

NCT07205900

Obese Obesity

RECRUITING PHASE2

A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)

NCT00092859

Obesity

COMPLETED PHASE3

Zonisamide for Weight Reduction in Obese Adults

NCT00275834

Obesity

COMPLETED NA

A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)

NCT00092872

Obesity

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Nutritional and Metabolic Diseases Metabolic Diseases Nutrition Disorders Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

001

R256918 10 mg capsule twice daily

Group Type EXPERIMENTAL

R256918

Intervention Type DRUG

10 mg capsule twice daily

002

R256918 15 mg capsule twice daily

Group Type EXPERIMENTAL

R256918

Intervention Type DRUG

15 mg capsule twice daily

003

placebo placebo capsule twice daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo capsule twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

R256918

10 mg capsule twice daily

Intervention Type DRUG

placebo

placebo capsule twice daily

Intervention Type DRUG

R256918

15 mg capsule twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No