A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of JNJ-16269110 on Hepatic Triglyceride Content in Obese Subjects - R256918OBE1008

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 sites81 target enrollmentJanuary 22, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Enrollment: 81
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 22, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Eligibility Criteria

Inclusion Criteria

•·Men or women
•·Between 18 and 65 years of age, inclusive
•·Women must be:
•·postmenopausal, defined as having a last menstrual period at least 1 year before screening with a serum follicle\-stimulating hormone (FSH) level consistent with postmenopausal status
•·or surgically incapable of childbearing (have had a hysterectomy or bilateral oophorectomy or tubal ligation or otherwise incapable of pregnancy)
•·or if sexually active, be practicing an effective method of birth control (such as hormonal contraceptives, intrauterine device (IUD), or having a vasectomized partner
•·or sexually abstinent
•·Women of childbearing potential must be practicing an effective method of birth control (as previously defined) and have a negative urine pregnancy test at screening as well as at the baseline visit before receiving study drug, which will be followed immediately by a serum beta\-human chorionic gonadotropin (b\-hCG) test. Subjects may be admitted to the study if the urine pregnancy test is negative, but will be discontinued immediately should the serum results be positive. Only a serum test is necessary at the end of the double\-blind treatment phase. During the double\-blind phase, a pregnancy test will be performed if pregnancy is suspected. Additional pregnancy tests may be performed at the discretion of the investigator.
•·Must be obese, defined as: BMI greater than or equal to 30 kg/m2 and \<50 kg/m2
•·If subjects are hypertensive, they must be controlled with appropriate drug treatment.

Exclusion Criteria

•·Any metal objects in the body or on the body that cannot be removed (including pacemaker, prostheses, bullets, certain types of tattoos, piercings, metal based IUDs, ferromagnetic surgical clips)
•·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
•·Prior exposure or known contraindication or hypersensitivity to JNJ 16269110
•·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 screening period
•·History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology (refer to Attachment 2, Interpretation of Hepatitis B Results for Enrolling Subjects at screening)
•·History of clinically significant GI disease (including but not limited to gluten\- and non\-gluten\-induced enteropathy, inflammatory bowel disease, malabsorption syndromes)
•·History of major GI surgery other than appendectomy or uncomplicated cholecystectomy.