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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Canagliflozin
* Drug: Phentermine
* Drug: Matching Placebo to Canagliflozin
* Drug: Matching Placebo to Phentermine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canagliflozin + Phentermine<br>300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks. | Drug: Canagliflozin<br>* 300 mg capsule, taken once daily, orally for 26 weeks.<br>* Other names: INVOKANA;Drug: Phentermine<br>* 15 mg capsule, taken once daily, orally for 26 weeks.<br>|
| Experimental: Canagliflozin + Placebo (Phentermine)<br>300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks. | Drug: Canagliflozin<br>* 300 mg capsule, taken once daily, orally for 26 weeks.<br>* Other names: INVOKANA;Drug: Matching Placebo to Phentermine<br>* Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.<br>|
| Experimental: Phentermine + Placebo (Canagliflozin)<br>15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks. | Drug: Phentermine<br>* 15 mg capsule, taken once daily, orally for 26 weeks.<br>Drug: Matching Placebo to Canagliflozin<br>* Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.<br>|
| Placebo Comparator: Placebo<br>Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks. | Drug: Matching Placebo to Canagliflozin<br>* Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.<br>Drug: Matching Placebo to Phentermine<br>* Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Body Weight at Week 26 | The percent change from baseline in body weight at Week 26 was analysed. | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26 | Percentage of participants with weight loss >= 5 percent were analysed at week 26. | Week 26 | 
| Change From Baseline in Systolic Blood Pressure at Week 26 | Change from baseline in systolic blood pressure was analysed at week 26. | Week 26 | 
| Absolute Change From Baseline in Body Weight at Week 26 | Absolute change from baseline in body weight was analysed at week 26. | Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Canagliflozin, Phentermine, INVOKANA®