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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Canagliflozin; Drug: Matching Placebo to Canagliflozin; Drug: Phentermine; Drug: Matching Placebo to Phentermine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02243202

CR103086

28431754OBE2002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 335 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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335 participants in 4 patient groups, including a placebo group

Canagliflozin + Phentermine

Experimental group

Description:

300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.

Treatment:

Drug: Phentermine

Drug: Canagliflozin

Canagliflozin + Placebo (Phentermine)

Experimental group

Description:

300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.

Treatment:

Drug: Matching Placebo to Phentermine

Drug: Canagliflozin

Phentermine + Placebo (Canagliflozin)

Experimental group

Description:

15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.

Treatment:

Drug: Matching Placebo to Canagliflozin

Drug: Phentermine

Placebo

Placebo Comparator group

Description:

Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.

Treatment:

Drug: Matching Placebo to Canagliflozin

Drug: Matching Placebo to Phentermine