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
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Canagliflozin (JNJ-28431754); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.; One matching placebo capsule orally once daily for 12 weeks.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Weight loss; Anti-Obesity Agents; Human