Obesity MedDRA version: 9.1 Level: LLT Classification code 10029883 Term: Obesity
Conditions
Interventions
Product Name: JNJ-16269110/10-mg/capsules
Product Code: F027
Pharmaceutical Form: Capsule, hard
CAS Number: 403989-79-7
Current Sponsor code: JNJ-16269110
Other descriptive name: R256918
Concentration
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion 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 ³30 kg/m2 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. · 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, including a history of myocardial infarction (MI), unstable angina and cerebrovascular accident (CVA) within 6 months of enrollment. · History of clinically significant cardiac valvular disease, or congestive heart failure (cardiovascular disability functional Class III-IV according to the New York Heart Association Classification of Cardiac Disease20, refer to Attachment 3) · 12-lead ECG showing evidence of clinically significant heart rhythm or conduction abnormality at screening or baseline. · An average of 3 seated readings where diastolic blood pressure ³100 mmHg or a systolic blood pressure ³160 mmHg · Thyroid-stimulating hormone (TSH) >1.5 times ULN at screening. Subjects on medication for hypothyroidism should have been on a stable dosage for at least 3 months before enrollment. · A significant change in smoking habits within 3 months of screening subjects planning to alter smoking habits during the course of the study · Malignancy or a history of a malignancy within 5 years before screening, other than basal cell carcinomas of the skin or in situ cervical carcinoma · History or evidence of clinically significant abnormal values for hematology, coagulation, or clinical biochemistry. · Increased LFTs, · ALT above 1.5 x ULN · any of the listed parameters: GGT, AST, total/direct bilirubin, alkaline phosphatase, or lactic acid dehydrogenase (LDH) above 2 x ULN · a concomitant increase of two or more of the above parameters, including: a. ALT> ULN and/or b. AST, total/direct bilirubin, alkaline phosphatase or LDH above 1.5 xULN and/or c. GGT above 2x ULN In doubtful or borderline cases, an additional retest sampling is allowed. · Increased creatinine kinase (CK) above ULN in subjects who take lipid lowering agents and CK level above 2 x ULN in subjects who do not take lipid lowering agents · Fasting triglycerides>6.77 mmol/L (600 mg/dL). A 1 time repeat of the fasting triglycerides is allowed (fasting is defined as no caloric intake for at least 8 hours before the test) · Evidence of renal impairmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate mean changes in Hepatic Triglyceride Content (HTGC) from baseline to week 6 and 12 by 1H-Magnetic Resonance Spectroscopy (MRS) in obese subjects treated with JNJ-16269110: 10 mg bid, 15 mg bid or placebo.;Secondary Objective: · To investigate time-course, dose-dependency and relationship of changes in HTGC to PK exposure · To evaluate changes in HTGC versus observed changes in weight of JNJ-16269110 versus placebo · To explore changes in obesity-associated co-morbidities as assessed by glucose homeostasis, fasting lipid profile, and systolic and diastolic blood pressure · To explore the effect of JNJ-16269110 on health status using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire · To explore patient-reported assessment of gastrointestinal (GI) symptoms · To assess safety and tolerability with specific emphasis on GI adverse events and hepatic function. · To assess pharmacokinetic (PK) exposure and to explore exposure-response relationships ;Primary end point(s): HTGC (Hepatic Triglyceride content) measured by MRS | — |
Countries
Finland, Netherlands, Sweden
Outcome results
None listed