CClinicalTrials.gg
Sign In
CompletedNCT00650806Updated May 24, 2013Results posted

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 interventional study of Canagliflozin (JNJ-28431754) and Placebo in Obesity, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 36 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-05-24.

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
376
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity

Keywords

  • Obesity
  • Overweight
  • Weight loss
  • Anti-Obesity Agents
  • Human
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 376 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
376 participants (actual)

Study arms

  • Experimental
    Canagliflozin 50 mg

    Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.

    Drug: Canagliflozin (JNJ-28431754)

  • Experimental
    Canagliflozin 100 mg

    Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.

    Drug: Canagliflozin (JNJ-28431754)

  • Experimental
    Canagliflozin 300 mg

    Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.

    Drug: Canagliflozin (JNJ-28431754)

  • Placebo comparator
    Placebo

    Each patient will receive matching placebo once daily for 12 weeks.

    Drug: Placebo

Interventions

  • DrugCanagliflozin (JNJ-28431754)

    One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

  • DrugPlacebo

    One matching placebo capsule orally once daily for 12 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 (Baseline) and Week 12

Secondary outcomes

  1. 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.

    Time frame: Day 1 (Baseline) and Week 12

  2. 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.

    Time frame: Day 1 (Baseline) and Week 12

  3. 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).

    Time frame: Day 1 (Baseline) and Week 12

  4. 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).

    Time frame: Day 1 (Baseline) and Week 12

  5. 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.

    Time frame: Day 1 (Baseline) and Week 12

  6. 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.

    Time frame: Day 1 (Baseline) and Week 12

  7. 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.

    Time frame: Day 1 (Baseline) and Week 12

07

Results

Posted May 24, 2013

Participant flow

This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) in nondiabetic, overweight, and obese patients. The study was conducted between 31 March 2008 and 18 September 2008 and recruited patients from 38 study centers located in the United States and Puerto Rico.

Participant flow — Overall Study
MilestonePlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Started89989396
Completed71776470
Not completed18212926
Withdrew: Adverse event0534
Withdrew: Lost to follow-up761110
Withdrew: Protocol violation0001
Withdrew: Pregnancy0001
Withdrew: Withdrawal by subject7586
Withdrew: Noncompliance with study drug regimen1100
Withdrew: Study terminated by sponsor2354
Withdrew: Other1120

Outcome measures

PrimaryPercent 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.

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Mean · Percent change
Percent Change in Body Weight From Baseline to Week 12
Percent changePlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanaglifloziin 300 mg
Percent Change in Body Weight From Baseline to Week 12-1.1 ± 2.4-2.0 ± 3.0-2.8 ± 2.9-2.5 ± 3.0
Statistical analysis
  • Placebo vs Canagliflozin 50 mg · ANOVA · p = 0.031 · Least-squares mean difference: -0.9 · 95% CI -1.6 to -0.1Cofactors were treatment, run-in weight loss stratum, and pooled center.
  • Placebo vs Canagliflozin 100 mg · ANOVA · p = <0.001 · Least-squares mean difference: -1.6 · 95% CI -2.4 to -0.8Cofactors were treatment, run-in weight loss stratum, and pooled center.
  • Placebo vs Canaglifloziin 300 mg · ANOVA · p = <0.001 · Least-squares mean difference: -1.4 · 95% CI -2.1 to -0.6Cofactors were treatment, run-in weight loss stratum, and pooled center.
SecondaryAbsolute 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.

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Mean · kg
Absolute Change in Body Weight From Baseline to Week 12
kgPlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Absolute Change in Body Weight From Baseline to Week 12-1.1 ± 2.46-1.9 ± 2.90-2.8 ± 2.90-2.4 ± 2.90
Statistical analysis
  • Placebo vs Canagliflozin 50 mg · ANCOVA · p = 0.045 · Least-squares mean difference: -0.8 · 95% CI -1.58 to -0.02Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -1.6 · 95% CI -2.40 to -0.80Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = 0.001 · Least-squares mean difference: -1.3 · 95% CI -2.07 to -0.51Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.
SecondaryChange 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.

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Mean · kg/m2
Change in Body Mass Index (BMI) From Baseline to Week 12
kg/m2PlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Change in Body Mass Index (BMI) From Baseline to Week 12-0.4 ± 0.86-0.7 ± 1.05-1.0 ± 1.05-0.9 ± 1.07
Statistical analysis
  • Placebo vs Canagliflozin 50 mg · ANCOVA · p = 0.031 · Least-squares mean difference: -0.31 · 95% CI -0.59 to -0.03Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -0.6 · 95% CI -0.90 to -0.32Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = <0.001 · Least-squares mean difference: -0.48 · 95% CI -0.76 to -0.20Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
SecondaryPercentage 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).

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Number · Percentage of patients
Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12
Percentage of patientsPlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 128.112.618.817.2
Statistical analysis
  • Placebo vs Canagliflozin 50 mg · Cochran-Mantel-Haenszel · p = 0.317 (P-value controlled for run-in weight loss stratum and pooled center.) · Odds ratio (or): 1.7 · 95% CI 0.6 to 5.6Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.
  • Placebo vs Canagliflozin 100 mg · Cochran-Mantel-Haenszel · p = 0.059 (P-value controlled for run-in weight loss stratum and pooled center.) · Odds ratio (or): 2.9 · 95% CI 0.9 to 11.1Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.
  • Placebo vs Canagliflozin 300 mg · Cochran-Mantel-Haenszel · p = 0.027 (P-value controlled for run-in weight loss stratum and pooled center.) · Odds ratio (or): 3.1 · 95% CI 1.0 to 10.0Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.
SecondaryPercentage 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).

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Number · Percentage of patients
Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12
Percentage of patientsPlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 120.03.22.41.1
Statistical analysis
  • Placebo vs Canagliflozin 50 mg · Cochran-Mantel-Haenszel · p = 0.117Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.
  • Placebo vs Canagliflozin 100 mg · Cochran-Mantel-Haenszel · p = 0.225Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.
  • Placebo vs Canagliflozin 300 mg · Cochran-Mantel-Haenszel · p = 0.317Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.
SecondaryChange 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.

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Mean · cm
Change in Waist Circumference From Baseline to Week 12
cmPlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Change in Waist Circumference From Baseline to Week 12-1.2 ± 10.06-1.4 ± 4.99-2.9 ± 10.32-2.6 ± 7.22
Statistical analysis
  • Placebo vs Canagliflozin 50 mg · ANCOVA · p = 0.835 · Least-squares mean difference: -0.26 · 95% CI -2.68 to 2.17Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = 0.466 · Least-squares mean difference: -0.94 · 95% CI -3.47 to 1.59Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = 0.273 · Least-sqaures mean difference: -1.37 · 95% CI -3.87 to 1.09Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
SecondaryChange 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.

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Mean · cm
Change in Hip Circumference From Baseline to Week 12
cmPlaceboCanaglifozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Change in Hip Circumference From Baseline to Week 120.1 ± 10.38-2.0 ± 3.97-2.1 ± 10.62-3.0 ± 7.95
Statistical analysis
  • Placebo vs Canaglifozin 50 mg · ANCOVA · p = 0.149 · Least-squares mean difference: -1.63 · 95% CI -3.85 to 0.59Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = 0.541 · Least-squares mean difference: -0.72 · 95% CI -3.05 to 1.6Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = 0.121 · Least-squares mean difference: -1.78 · 95% CI -4.03 to 0.47Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
SecondaryChange 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.

Time frame:
Day 1 (Baseline) and Week 12
Reported as:
Mean · ratio
Change in Waist/Hip Ratio From Baseline to Week 12
ratioPlaceboCanaglifozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Change in Waist/Hip Ratio From Baseline to Week 12-0.011 ± 0.05420.003 ± 0.0422-0.008 ± 0.0915-0.004 ± 0.0469
Statistical analysis
  • Placebo vs Canaglifozin 50 mg · ANCOVA · p = 0.239 · Least-squares mean difference: 0.011 · 95% CI -0.0071 to 0.0286Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 100 mg · ANCOVA · p = 0.900 · Least-squares mean difference: 0.001 · 95% CI -0.0174 to 0.0198Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.
  • Placebo vs Canagliflozin 300 mg · ANCOVA · p = 0.822 · Least-squares mean difference: 0.002 · 95% CI -0.0160 to 0.0202Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.

Adverse events

Collected over Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/89 (0%)28/89 (31.5%)
Canagliflozin 50 mg—1/98 (1%)41/98 (41.8%)
Canagliflozin 100 mg—0/93 (0%)30/93 (32.3%)
Canagliflozin 300 mg—0/96 (0%)31/96 (32.3%)
Most frequent serious events
Most frequent serious events
EventPlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
ArthralgiaMusculoskeletal and connective tissue disorders0/891/980/930/96
Most frequent other events
Most frequent other events
EventPlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mg
Vulvovaginal mycotic infectionInfections and infestations1/898/985/9314/96
HeadacheNervous system disorders7/896/9811/934/96
Urinary tract infectionInfections and infestations6/8910/987/938/96
NauseaGastrointestinal disorders2/897/986/933/96
Upper respiratory tract infectionInfections and infestations5/896/986/935/96
NasopharyngitisInfections and infestations3/896/981/931/96
SinusitisInfections and infestations0/896/982/931/96
DiarrhoeaGastrointestinal disorders5/895/983/932/96
ConstipationGastrointestinal disorders2/895/983/932/96

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mgTotal
<=18 years00000
Between 18 and 65 years88979394372
>=65 years11024
Age Continuous
Age Continuous(years)PlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mgTotal
Mean45.1 ± 11.9244.9 ± 11.845.8 ± 10.9543.5 ± 10.9944.8 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mgTotal
Female75867686323
Male1412171053
Region Enroll
Region Enroll(participants)PlaceboCanagliflozin 50 mgCanagliflozin 100 mgCanagliflozin 300 mgTotal
PUERTO RICO344516
UNITED STATES86948991360
08

Study locations

36 sites
  • Hot Springs, Arkansas, United States
  • Walnut Creek, California, United States
  • Westlake Village, California, United States
  • Destin, Florida, United States
  • Jacksonville, Florida, United States
  • Augusta, Georgia, United States
  • Decatur, Georgia, United States
  • Stockbridge, Georgia, United States
  • Boise, Idaho, United States
  • Eagle, Idaho, United States
  • Meridian, Idaho, United States
  • Evansville, Indiana, United States
  • Overland Park, Kansas, United States
  • Witchita, Kansas, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Auburn, Maine, United States
  • Milford, Massachusetts, United States
  • Jackson, Mississippi, United States
  • Omaha, Nebraska, United States
  • Manilus, New York, United States
  • Medford, Oregon, United States
  • Portland, Oregon, United States
  • Goose Creek, South Carolina, United States
  • Mt Pleasant, South Carolina, United States
  • Knoxville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Amarillo, Texas, United States
  • Dallas, Texas, United States
  • Odessa, Texas, United States
  • San Antonio, Texas, United States
  • West Jordan, Utah, United States
  • Norfolk, Virginia, United States
  • Wauwatosa, Wisconsin, United States
  • Ponce, Puerto Rico
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00650806
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible party
Sponsor
First posted
Apr 2, 2008
Start date
May 2008
Primary completion
Sep 2008
Completion
Sep 2008
Results posted
May 24, 2013
Last update
May 24, 2013

Study contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Obesity→

Other studies from this sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Start the discussion