ObesityPhase 2NCT00622765
A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese Patients
A Phase 2 study testing R256918 in people with Obesity and Nutritional and Metabolic Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 18 sites in 7 countries.
Trial summary
This study investigates the effectiveness and safety of 12 weeks of treatment with JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of effectiveness is the change in body weight at a clinically relevant dosage level during treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Nutritional and Metabolic Diseases, Metabolic Diseases
- What is being tested?
- R256918
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 18 sitesin 7 countries
- Study dates
- Nov 2007to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese or overweight at screening defined as: BMI greater than or equal to 30 kg/m2 and <50 kg/m2 or BMI greater than or equal to 27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia. For patients 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. 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 patients who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C greater than or equal to 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 greater than or equal to 1.7 mmol/L (150 mg/dL)
- 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 patients's history of having no difficulty with swallowing e.g., capsules or intact tablets
- Fasting plasma glucose <7.0 mmol/L (126 mg/dL) at screening
- Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control
Who cannot join
- 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 R256918
- 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
Show all 19Show fewer
- History or evidence of liver or renal impairment
- 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 or hypertension
- Elevated levels of thyroid-stimulating hormone (TSH)
- A significant change in smoking habits within 3 months of the start of the run-in period
- 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 of seizures or significant central nervous system-related disorders
- History of significant psychiatric disorder, including, schizophrenia, or psychosis
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Denmark3 sites
Study site
Frederiksberg C N/A
Study site
Hellerup
Study site
Vipperroed
Netherlands3 sites
Study site
Amsterdam
Study site
Hilversum
Study site
Rotterdam
United Kingdom3 sites
Study site
Liverpool
Study site
London
Study site
Luton
About this study
Official title: 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
This study investigates the effectiveness and safety of 12 weeks of treatment with JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of effectiveness is the change in body weight at a clinically relevant dosage level during treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry which is a specialized x-ray test that measures body composition), fasting glucose, lipid levels, and blood pressure. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.
Read the detailed description
This is a randomized (assigned study drug by chance), double-blind (both the patient and investigator do not know whether patient is assigned to receive study drug or placebo), placebo-controlled study involving overweight and obese patients. Patients are randomized to one of 4 treatment groups and receive study drug or placebo for a period of 12 weeks. The study consists of 3 phases: a pretreatment phase (including a screening period of 1 week and a period prior to active treatment of 4 weeks), the treatment period of 12 weeks, and a posttreatment phase (consisting of a follow-up visit). Standardized nonpharmacologic therapy (individualized calorie deficit diets containing no more than 30% calories from fat and nutritional counseling) will be administered from Week 4 through the follow-up period. During the treatment period, patients visit the center every two weeks. On each visit, patients come to the clinic after 8 hours fasting. For effectiveness assessments, patients will be weighed and BMI calculated at each visit; waist and hip circumference and DEXA measurements (for body composition and fat mass analysis) will be performed at selected time points. Additional effectiveness assessments from a blood sample include levels of fasting hemoglobin type A1c (HbA1c), glucose, cholesterol, triglycerides, insulin, C-peptide, and gastrointestinal hormones. Insulin sensitivity and pancreas function are evaluated. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms, are performed during the study. Patients complete a questionnaire related to stomach/bowel symptoms (GI) throughout the study. Blood samples will also be drawn for an analysis of the subjects genes and an analyses of the body's handling of the study drug. The overall duration of the study for each patient is approximately 19 weeks. The study hypothesis is that treatment with JNJ-16269110 (R256918) will cause a change in body weight compared to placebo and will be well tolerated in overweight and obese patients. This hypothesis will be investigated at each dosage level to determine a clinically relevant dose. 5 mg capsules, 10 mg capsules, 15 mg capsules, or matching placebo capsules taken orally.
- Conditions
- Obesity, Nutritional and Metabolic Diseases, Metabolic Diseases, Nutrition Disorders, Overweight
- Being tested
- placebo, R256918
- Keywords
- Obesity, Overweight, Body Weight, Body Size, Nutritional and Metabolic Diseases
- Medical subject headings
- Obesity, Nutritional and Metabolic Diseases, Metabolic Diseases, Nutrition Disorders, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Placebo capsule twice daily
R256918Drug
5 mg capsule twice daily
R256918Drug
10 mg capsule twice daily
R256918Drug
15 mg capsule twice daily
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | R256918 5 mg capsule twice daily Receives: Drug: R256918 |
| 002 | Experimental | R256918 10 mg capsule twice daily Receives: Drug: R256918 |
| 003 | Experimental | R256918 15 mg capsule twice daily Receives: Drug: R256918 |
| 004 | Placebo comparator | placebo Placebo capsule twice daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in body weight from baseline to Week 12.
Measured: Baseline, 12 weeks
Secondary outcomes (3)
Changes in body weight, body mass index (BMI), body composition, blood pressure, glucose, intestinal hormone levels, beta cell function and lipid parameters.
Measured: 12 weeks
Quality of Life scores on questionnaires.
Measured: 12 weeks
Safety parameters monitored at each visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622765
- Sponsor's protocol ID
- CR011362
- Other IDs
- R256918OBE2001
- Status last verified
- Apr 2014
- First submitted
- 21 Dec 2007
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00622765
- Acronym / sponsor ID
- CR011362
- Conditions
- Obesity, Nutritional and Metabolic Diseases, Metabolic Diseases, Nutrition Disorders, Overweight
- Keywords
- Obesity, Overweight, Body Weight, Body Size, Nutritional and Metabolic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effectiveness and safety of 12 weeks of treatment with JNJ-16269110 (R256918), in overweight and obese patients. The primary measure of effectiveness is the change in body weight at a clinically relevant dosage level during treatment. Additional measures include body mass index (BMI), DEXA (dual X-ray absorptiometry which is a specialized x-ray test that measures body composition), fasting glucose, lipid levels, and blood pressure. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.
Detailed description
This is a randomized (assigned study drug by chance), double-blind (both the patient and investigator do not know whether patient is assigned to receive study drug or placebo), placebo-controlled study involving overweight and obese patients. Patients are randomized to one of 4 treatment groups and receive study drug or placebo for a period of 12 weeks. The study consists of 3 phases: a pretreatment phase (including a screening period of 1 week and a period prior to active treatment of 4 weeks), the treatment period of 12 weeks, and a posttreatment phase (consisting of a follow-up visit). Standardized nonpharmacologic therapy (individualized calorie deficit diets containing no more than 30% calories from fat and nutritional counseling) will be administered from Week 4 through the follow-up period. During the treatment period, patients visit the center every two weeks. On each visit, patients come to the clinic after 8 hours fasting. For effectiveness assessments, patients will be weighed and BMI calculated at each visit; waist and hip circumference and DEXA measurements (for body composition and fat mass analysis) will be performed at selected time points. Additional effectiveness assessments from a blood sample include levels of fasting hemoglobin type A1c (HbA1c), glucose, cholesterol, triglycerides, insulin, C-peptide, and gastrointestinal hormones. Insulin sensitivity and pancreas function are evaluated. Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms, are performed during the study. Patients complete a questionnaire related to stomach/bowel symptoms (GI) throughout the study. Blood samples will also be drawn for an analysis of the subjects genes and an analyses of the body's handling of the study drug. The overall duration of the study for each patient is approximately 19 weeks. The study hypothesis is that treatment with JNJ-16269110 (R256918) will cause a change in body weight compared to placebo and will be well tolerated in overweight and obese patients. This hypothesis will be investigated at each dosage level to determine a clinically relevant dose. 5 mg capsules, 10 mg capsules, 15 mg capsules, or matching placebo capsules taken orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: R256918R256918 5 mg capsule twice daily |
| 002 | Experimental | Drug: R256918R256918 10 mg capsule twice daily |
| 003 | Experimental | Drug: R256918R256918 15 mg capsule twice daily |
| 004 | Placebo comparator | Drug: placeboplacebo Placebo capsule twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Obese or overweight at screening defined as: BMI greater than or equal to 30 kg/m2 and <50 kg/m2 or BMI greater than or equal to 27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia. For patients 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. 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 patients who are not on lipid-lowering drugs, dyslipidemia is defined as LDL-C greater than or equal to 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 greater than or equal to 1.7 mmol/L (150 mg/dL)
- 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 patients's history of having no difficulty with swallowing e.g., capsules or intact tablets
- Fasting plasma glucose <7.0 mmol/L (126 mg/dL) at screening
Key exclusion criteria (19 listed)
- 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 R256918
- History of weight-reducing diet or receiving any drugs to treat obesity within the 3 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboPlacebo capsule twice daily | Drug | 004 |
| R2569185 mg capsule twice daily | Drug | 001 |
| R25691810 mg capsule twice daily | Drug | 002 |
| R25691815 mg capsule twice daily | Drug | 003 |
Primary outcome
Mean change in body weight from baseline to Week 12.
Time frame: Baseline, 12 weeks
3 secondary outcomes
Changes in body weight, body mass index (BMI), body composition, blood pressure, glucose, intestinal hormone levels, beta cell function and lipid parameters.
Time frame: 12 weeks
Quality of Life scores on questionnaires.
Time frame: 12 weeks
Safety parameters monitored at each visit.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Dose-Ranging Study to Investigate the Safety and Efficacy of JNJ-16269110 in Overweight and Obese SubjectsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R256918 in people with Obesity and Nutritional and Metabolic Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Denmark, Germany, Netherlands, United Kingdom, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in body weight from baseline to Week 12. (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.