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 Research & Development, LLC335 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

335

Conditions

Obesity

Interventions

CanagliflozinDRUG

300 mg capsule, taken once daily, orally for 26 weeks.

PhentermineDRUG

15 mg capsule, taken once daily, orally for 26 weeks.

Matching Placebo to CanagliflozinDRUG

Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (17)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Walnut Creek, California, United States

Unnamed facility

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Percent Change From Baseline in Body Weight at Week 26

The percent change from baseline in body weight at Week 26 was analysed.

Time frame: Week 26

Secondary Outcomes

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.

Time frame: Week 26

Change From Baseline in Systolic Blood Pressure at Week 26

Change from baseline in systolic blood pressure was analysed at week 26.

Time frame: Week 26

Absolute Change From Baseline in Body Weight at Week 26

Absolute change from baseline in body weight was analysed at week 26.

Time frame: Week 26

Data from ClinicalTrials.gov

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