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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00650806

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

376

Starts

2008-05-01

Expected to finish

2008-09-01

Last updated by the study team

2013-05-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Hot Springs, Arkansas, United States
• Study site — Walnut Creek, California, United States
• Study site — Westlake Village, California, United States
• Study site — Destin, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Stockbridge, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Eagle, Idaho, United States
• Study site — Meridian, Idaho, United States
• Study site — Evansville, Indiana, United States
• Study site — Overland Park, Kansas, United States
• Study site — Witchita, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Auburn, Maine, United States
• Study site — Milford, Massachusetts, United States
• Study site — Jackson, Mississippi, United States
• Study site — Omaha, Nebraska, United States
• Study site — Manilus, New York, United States
• Study site — Medford, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Goose Creek, South Carolina, United States

Full record on ClinicalTrials.gov

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