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

Phase 2

Conditions: corpulence- obesity
10003018

Registration Number: NL-OMON30928

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

· Men or women
· Between 18 and 65 years of age, inclusive
· Women must be:
· postmenopausal,
· or surgically incapable of childbearing
· or sexually abstinent
· Women of childbearing potential must be practicing an acceptable method of birth control and have had 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. · Must be obese or overweight at screening (start of run-in period), defined as:
· BMI *30 kg/m2 and <50 kg/m2 or
· BMI *27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia. For subjects 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. There should be no anticipated changes to antihypertensive or lipid-lowering medications during the course of the study.
· 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 subjects who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C *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 *1.7 mmol/L (150 mg/dL).
· If subjects are clinically diagnosed with dyslipidemia as a result of screening assessments, they can only continue in the run-in phase of the study if in the clinical judgment of the investigator initiation of lipid-lowering therapy is not required either immediately or during the course of the study.
· 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
· Fasting plasma glucose24 <7.0 mmol/L (126 mg/dL) at screening

Exclusion Criteria

· History of obesity with a known cause
· 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 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 start of the run-in period
· History or evidence of liver disease
· 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 within 6 months of enrollment.
· History of clinically significant cardiac valvular disease, or congestive heart failure
· 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 *100 mmHg or a systolic blood pressure *160 mmHg at screening
· 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 (the start of the run-in period).
· A significant change in smoking habits within 3 months of the start of the run-in period; subjects planning to alter smoking habits during the course of the study
· 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 or evidence of clinically significant abnormal values for hematology, coagulation, or clinical biochemistry.
· Increased liver function tests,
· ALT above 1.5 X ULN
· ALT above ULN but less than 1.5 X ULN with a concomitant increase of AST, bilirubin, alkaline phosphatase or LDH above 1.5 X ULN or GGT above 2x ULN at screening.
· 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 at screening visit.
· Fasting TG >33.3 mmol/L (600 mg/dL) at screening.
· Evidence of renal impairment (serum creatinine >133 mmol/L (1.5 mg/dL) in men, >124 mmol/L (1.4 mg/dL) in women)
· History of drug or alcohol abuse within the previous 2 years
· Alcohol consumption exceeding 4 units per day for men or 3 units per day for women
· Receiving any excluded medication (see section 8)
· History of seizures or significant central nervous system-related disorders
· History of significant psychiatric disorder, including, schizophrenia, or psychosis (depressive disorders do not preclude participation in the trial)
· Current use of cannabinoids

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to find the appropriate, clinically<br /><br>relevant dosages (among the 5, 10, and 15 mg twice-daily dosages) of<br /><br>JNJ-16269110 by assessing mean changes in body weight from baseline to Week 12,<br /><br>compared to placebo </p><br>

Secondary Outcome Measures