ObesityPhase 2NCT00650806
A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes
A Phase 2 study testing Canagliflozin (JNJ-28431754) in people with Obesity, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 36 sites in 2 countries.
Trial summary
The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Canagliflozin (JNJ-28431754)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 36 sitesin 2 countries
- Study dates
- May 2008to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- BMI >=30 kg/m2 and <50 kg/m2 or a BMI >=27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia
- Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3 months before screening
- Serum creatinine <=1.5 mg/dL for men and <=1.4 mg/dL for women at screening
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2 times the upper limit of normal (ULN) and bilirubin within the normal range, unless the findings are consistent with Gilbert's disease
- fasting plasma glucose PG <7.0 mmol/L (126 mg/dL) at screening
Who cannot join
- A history of hereditary glucose-galactose malabsorption or primary renal glycosuria
- An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs at screening
- A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia
- Fasting triglyceride level >6.78 mmol/L (600 mg/dL) at screening
- History of obesity with a known cause (e.g., Cushing's disease)
Trial locations and contacts
36 sites in 2 countries.
36 sites in 2 countries
United States35 sites
Study site
Amarillo, Texas
Study site
Auburn, Maine
Study site
Augusta, Georgia
Study site
Boise, Idaho
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
Destin, Florida
Study site
Eagle, Idaho
Study site
Evansville, Indiana
Study site
Goose Creek, South Carolina
Study site
Hot Springs, Arkansas
Study site
Jackson, Mississippi
Study site
Jacksonville, Florida
Study site
Knoxville, Tennessee
Study site
Lexington, Kentucky
Study site
Louisville, Kentucky
Study site
Manilus, New York
Study site
Medford, Oregon
Study site
Meridian, Idaho
Study site
Milford, Massachusetts
Study site
Mt. Pleasant, South Carolina
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Norfolk, Virginia
Study site
Odessa, Texas
Study site
Omaha, Nebraska
Study site
Overland Park, Kansas
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
Stockbridge, Georgia
Study site
Walnut Creek, California
Study site
Wauwatosa, Wisconsin
Study site
West Jordan, Utah
Study site
Westlake Village, California
Study site
Witchita, Kansas
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Investigate the Safety and Efficacy of JNJ-28431754 in Nondiabetic Overweight and Obese Subjects
The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.
Read the detailed description
The prevalence of obesity is increasing worldwide. Obesity and being overweight are major risk factors for chronic cardiovascular disease, type 2 diabetes mellitus, hypertension and stroke, and certain types of cancers. JNJ-28431754 is being investigated in this study for its possible effectiveness in promoting weight loss when taken over a 12-week period. The study consists of 3 phases: a pretreatment phase that includes a 7-day screening period and a 4-week run-in period, a 12-week double-blind treatment phase (neither the patient nor the investigator will know which treatment the patient is receiving) with an end-of-treatment visit, and a posttreatment phase. In the pretreatment phase, after giving written informed consent, patients will undergo screening evaluations. Patients who successfully complete the screening period will enter the 4-week run-in period and be given dietary and exercise counseling as standardized non-drug therapy for weight loss. During the 12 weeks of treatment, all patients will continue on the study diet and exercise non-drug therapy and will visit the study site about every 3 weeks to have their weight and the results of other safety and effectiveness tests recorded, and to have blood samples collected to measure the concentration of JNJ-28431754 in their blood. In the posttreatment phase, patients will return to the study site for a follow-up visit 14 days after receiving their last dose of study drug. Patient safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); pregnancy tests; physical examinations; electrocardiograms; vital signs measurements; overnight urine collection to measure albumin excretion; assessment of calcium and phosphate homeostasis (balance), bone formation and reabsorption markers, and hormones regulating calcium and phosphorus homeostasis; and self administered vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis and urinary tract infection. Patients will complete 2 questionnaires to record their reactions to taking the study drug and the effect of body weight on their daily lives. About 100 patients of the approximately 400 who qualify for the study, and who consent to this, will take part in 2 oral glucose tolerance tests (OGTTs). During the OGTTs they will drink a glucose solution and have a series of blood samples collected to measure glucose concentration, collect their urine over a 2 hour period, and (at the second OGTT only) have blood samples collected to measure JNJ 28431754 blood concentrations. The primary clinical theory for this study is that at well-tolerated doses, JNJ-28431754 is superior to placebo as measured by the percent change in body weight from baseline (Day 1 of the double-blind treatment period) through Week 12.
- Conditions
- Obesity
- Being tested
- Canagliflozin (JNJ-28431754), Placebo
- Keywords
- Obesity, Overweight, Weight loss, Anti-Obesity Agents, Human
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin (JNJ-28431754)Drug
One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.
PlaceboDrug
One matching placebo capsule orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin 50 mg | Experimental | Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. Receives: Drug: Canagliflozin (JNJ-28431754) |
| Canagliflozin 100 mg | Experimental | Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. Receives: Drug: Canagliflozin (JNJ-28431754) |
| Canagliflozin 300 mg | Experimental | Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. Receives: Drug: Canagliflozin (JNJ-28431754) |
| Placebo | Placebo comparator | Each patient will receive matching placebo once daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Body Weight From Baseline to Week 12
The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.
Measured: Day 1 (Baseline) and Week 12
Secondary outcomes (7)
Absolute Change in Body Weight From Baseline to Week 12
The table below shows the mean absolute change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Change in Body Mass Index (BMI) From Baseline to Week 12
The table below shows the mean change in BMI from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12
The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).
Measured: Day 1 (Baseline) and Week 12
Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12
The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo).
Measured: Day 1 (Baseline) and Week 12
Change in Waist Circumference From Baseline to Week 12
The table below shows the mean change in waist circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Change in Hip Circumference From Baseline to Week 12
The table below shows the mean change in hip circumference from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Change in Waist/Hip Ratio From Baseline to Week 12
The table below shows the mean change in waist/hip ratio from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean change.
Measured: Day 1 (Baseline) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 376 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
- NCT00650806
- Sponsor's protocol ID
- CR014578
- Other IDs
- 28431754OBE2001
- Status last verified
- Apr 2013
- First submitted
- 31 Mar 2008
- Last updated
- 24 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. 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-28431754 in Nondiabetic Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT00650806
- Acronym / sponsor ID
- CR014578
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Weight loss, Anti-Obesity Agents, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 24 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.
Detailed description
The prevalence of obesity is increasing worldwide. Obesity and being overweight are major risk factors for chronic cardiovascular disease, type 2 diabetes mellitus, hypertension and stroke, and certain types of cancers. JNJ-28431754 is being investigated in this study for its possible effectiveness in promoting weight loss when taken over a 12-week period. The study consists of 3 phases: a pretreatment phase that includes a 7-day screening period and a 4-week run-in period, a 12-week double-blind treatment phase (neither the patient nor the investigator will know which treatment the patient is receiving) with an end-of-treatment visit, and a posttreatment phase. In the pretreatment phase, after giving written informed consent, patients will undergo screening evaluations. Patients who successfully complete the screening period will enter the 4-week run-in period and be given dietary and exercise counseling as standardized non-drug therapy for weight loss. During the 12 weeks of treatment, all patients will continue on the study diet and exercise non-drug therapy and will visit the study site about every 3 weeks to have their weight and the results of other safety and effectiveness tests recorded, and to have blood samples collected to measure the concentration of JNJ-28431754 in their blood. In the posttreatment phase, patients will return to the study site for a follow-up visit 14 days after receiving their last dose of study drug. Patient safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); pregnancy tests; physical examinations; electrocardiograms; vital signs measurements; overnight urine collection to measure albumin excretion; assessment of calcium and phosphate homeostasis (balance), bone formation and reabsorption markers, and hormones regulating calcium and phosphorus homeostasis; and self administered vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis and urinary tract infection. Patients will complete 2 questionnaires to record their reactions to taking the study drug and the effect of body weight on their daily lives. About 100 patients of the approximately 400 who qualify for the study, and who consent to this, will take part in 2 oral glucose tolerance tests (OGTTs). During the OGTTs they will drink a glucose solution and have a series of blood samples collected to measure glucose concentration, collect their urine over a 2 hour period, and (at the second OGTT only) have blood samples collected to measure JNJ 28431754 blood concentrations. The primary clinical theory for this study is that at well-tolerated doses, JNJ-28431754 is superior to placebo as measured by the percent change in body weight from baseline (Day 1 of the double-blind treatment period) through Week 12.
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 |
|---|---|---|
| Canagliflozin 50 mg | Experimental | Drug: Canagliflozin (JNJ-28431754)Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| Canagliflozin 100 mg | Experimental | Drug: Canagliflozin (JNJ-28431754)Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| Canagliflozin 300 mg | Experimental | Drug: Canagliflozin (JNJ-28431754)Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboEach patient will receive matching placebo once daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI >=30 kg/m2 and <50 kg/m2 or a BMI >=27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia
- Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3 months before screening
- Serum creatinine <=1.5 mg/dL for men and <=1.4 mg/dL for women at screening
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2 times the upper limit of normal (ULN) and bilirubin within the normal range, unless the findings are consistent with Gilbert's disease
- fasting plasma glucose PG <7.0 mmol/L (126 mg/dL) at screening
Key exclusion criteria (5 listed)
- A history of hereditary glucose-galactose malabsorption or primary renal glycosuria
- An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs at screening
- A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia
- Fasting triglyceride level >6.78 mmol/L (600 mg/dL) at screening
- History of obesity with a known cause (e.g., Cushing's disease)
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 |
|---|---|---|
| Canagliflozin (JNJ-28431754)One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks. | Drug | Canagliflozin 100 mg, Canagliflozin 300 mg, Canagliflozin 50 mg |
| PlaceboOne matching placebo capsule orally once daily for 12 weeks. | Drug | Placebo |
Primary outcome
Percent Change in Body Weight From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.
7 secondary outcomes
Absolute Change in Body Weight From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Change in Body Mass Index (BMI) From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12
Time frame: Day 1 (Baseline) and Week 12
Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12
Time frame: Day 1 (Baseline) and Week 12
Change in Waist Circumference From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Change in Hip Circumference From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Change in Waist/Hip Ratio From Baseline to Week 12
Time frame: Day 1 (Baseline) and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
36 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canagliflozin (JNJ-28431754) in people with Obesity, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 36 sites in 2 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 5 inclusion and 5 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 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 24 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Body Weight From Baseline to Week 12 (time frame: Day 1 (Baseline) and Week 12). 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 24 May 2013.