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

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