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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Canagliflozin; Phentermine

Criteria

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