Conditions: Obesity
Keywords: Obesity Overweight Canagliflozin Phentermine INVOKANA®
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 335
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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).

Arms:
arm 1: 300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks. arm 2: 300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks. arm 3: 15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks. arm 4: Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.

Interventions: intervention 1: Canagliflozin intervention 2: Phentermine intervention 3: Matching Placebo to Canagliflozin intervention 4: Matching Placebo to Phentermine
Intervention descriptions: intervention 1: 300 mg capsule, taken once daily, orally for 26 weeks. intervention 2: 15 mg capsule, taken once daily, orally for 26 weeks. intervention 3: Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks. intervention 4: Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.

Protocol document: