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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: Phentermine; Drug: Canagliflozin; Drug: Matching Placebo to Phentermine; Drug: Matching Placebo to Canagliflozin

• Registration Number: NCT02243202
• Lead Sponsor: Janssen Research & Development, LLC

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).

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-17
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-06-16
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Results First Posted: 2016-10-06
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canagliflozin + Placebo (Phentermine)	Matching Placebo to Phentermine	300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
Phentermine + Placebo (Canagliflozin)	Phentermine	15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
Placebo	Matching Placebo to Phentermine	Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
Canagliflozin + Phentermine	Canagliflozin	300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
Canagliflozin + Phentermine	Phentermine	300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
Phentermine + Placebo (Canagliflozin)	Matching Placebo to Canagliflozin	15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
Placebo	Matching Placebo to Canagliflozin	Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
Canagliflozin + Placebo (Phentermine)	Canagliflozin	300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight at Week 26	Week 26	The percent change from baseline in body weight at Week 26 was analysed.

Secondary Outcome Measures

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