A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

• BMI >=30 kg/m2 and <50 kg/m2 or a BMI >=27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia

• Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3 months before screening

• Serum creatinine <=1.5 mg/dL for men and <=1.4 mg/dL for women at screening

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2 times the upper limit of normal (ULN) and bilirubin within the normal range, unless the findings are consistent with Gilbert's disease

• fasting plasma glucose PG <7.0 mmol/L (126 mg/dL) at screening

Exclusion Criteria:

• A history of hereditary glucose-galactose malabsorption or primary renal glycosuria

• An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs at screening

• A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia

• Fasting triglyceride level >6.78 mmol/L (600 mg/dL) at screening

• History of obesity with a known cause (e.g., Cushing's disease)