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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2006-006772-38-NL |
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Date of registration:
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30/08/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 - N/A
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Scientific title:
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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 - N/A |
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Date of first enrolment:
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13/11/2007 |
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Target sample size:
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320 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006772-38 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Denmark
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Finland
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Germany
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Netherlands
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
1 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 (e.g. spermicide plus barrier, hormonal contraceptive, intrauterine device, or a partner with a vasectomy);
· or sexually abstinent
· Women of childbearing potential must be practicing an acceptable method of birth control (as previously defined) 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. 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 or overweight at screening (start of run-in period), defined as:
· BMI ³30 kg/m2 and <50 kg/m2 or
· BMI ³27 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.22
· For subjects who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C ³3.4 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 ³1.7 mmol/L (150 mg/dL).23
· 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
· 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 subject's history of having no difficulty with swallowing e.g. capsules or intact tablets.
· Fasting plasma glucose24 <7.0 mmol/L (126 mg/dL) at screening; in cases in which there is doubt concerning fasting conditions, a 1-time repeat of the fasting plasma glucose is allowed (fasting is defined as no caloric intake for at least 8 hours before the test)
· Willing to adhere to the prohibitions and restrictions specified in this protocol
· Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willi
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 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, including cirrhosis or nonalcoholic steatohepatitis/non-alcoholic fatty liver disease,
· 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 gastro-intestinal disease (including but not limited to gluten- and non-gluten-induced enteropathy, inflammatory bowel disease, malabsorption syndromes)
· 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, 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 Disease25; 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 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).
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Obesity
MedDRA version: 9.1
Level: LLT
Classification code 10029883
Term: Obesity
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Intervention(s)
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Product Name: JNJ-16269110/5-mg/capsules filled with beads
Product Code: F026
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not Assigned
CAS Number: 403989-79-7
Current Sponsor code: JNJ-16269110-AAA
Other descriptive name: R256918
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: JNJ-16269110/10-mg/capsules filled with beads
Product Code: F027
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not Assigned
CAS Number: 403989-79-7
Current Sponsor code: JNJ-16269110-AAA
Other descriptive name: R256918
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: JNJ-16269110/15-mg/capsules filled with beads
Product Code: F028
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not Assigned
CAS Number: 403989-79-7
Current Sponsor code: JNJ-16269110-AAA
Other descriptive name: R256918
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective of the study is to find the appropriate, clinically relevant dosages (among the 5, 10, and 15 mg twice-daily dosages) of JNJ-16269110 by assessing mean changes in body weight from baseline to Week 12, compared to placebo.
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Primary end point(s): To evaluate the efficacy, safety and tolerability of JNJ-16269110
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Secondary Objective: To estimate the dose-response relationship between the different dosages of JNJ-16269110 and the decrease in body weight from baseline to Week 12
To estimate the effect on weight loss of different JNJ-16269110 dosages versus placebo as expressed by mean percent change from baseline in body weight and in body mass index (BMI), and the percentage of subjects who lose at least 5% or 10% of their initial body weight
To estimate changes in body composition using anthropometric measurements and by means of Dual X Ray Absorptiometry (DEXA [only at selected sites] to explore if weight loss is predominantly due to loss of fat mass
To explore changes in obesity-associated comorbidities as assessed by glucose homeostasis, fasting lipid profile, and systolic and diastolic blood pressure
To explore the effect of JNJ-16269110 on changes in levels of PYY, GLP 1, and oxyntomodulin
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Secondary ID(s)
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2006-006772-38-BE
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R256918OBE2001
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N/A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 13/11/2007
Contact:
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