Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT02243202
- Run by
- Janssen Research & Development, LLC
- People needed
- 335
- Starts
- 2014-09-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2016-10-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Phoenix, Arizona, United States
- Study site — Walnut Creek, California, United States
- Study site — Jacksonville, Florida, United States
- Study site — Meridian, Idaho, United States
- Study site — Evansville, Indiana, United States
- Study site — Lexington, Kentucky, United States
- Study site — Louisville, Kentucky, United States
- Study site — New Orleans, Louisiana, United States
- Study site — Milford, Massachusetts, United States
- Study site — Manlius, New York, United States
- Study site — Warwick, Rhode Island, United States
- Study site — Mt. Pleasant, South Carolina, United States
- Study site — Nashville, Tennessee, United States
- Study site — Dallas, Texas, United States
- Study site — Odessa, Texas, United States
- Study site — Norfolk, Virginia, United States
- Study site — Wauwatosa, Wisconsin, United States
Full record on ClinicalTrials.gov
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