Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects

The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).

Inclusion Criteria:

• Must have BMI >=30 kg/m2 and <50 kg/m2 at screening or BMI >=27 kg/m2 and <50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
• Must have stable weight, ie, change of < =5% in the 3 months before screening
• Must agree to utilize a highly effective method of birth control

Exclusion Criteria:

• An established diagnosis of diabetes mellitus
• Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
• Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
• Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
• Has an Glycated hemoglobin (HBA1c) greater than or equal (>=) to 65 percent
• An average of 3 seated blood pressure (BP) readings of systolic BP >= 160 mm Hg and/or Diastolic BP >= 100 millimeters of mercury at screening