A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity

A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 12 Weeks Treatment With 4 Doses of LIK066 Compared to Placebo in Japanese Patients With Obesity Disease

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.

Inclusion Criteria:

• Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
• BMI ≥ 25 kg/m^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m^2 at least one obesity-related comorbidity
• Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%
• Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female
• Visceral fat area ≥ 100 cm^2
• Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study

Exclusion Criteria:

• Pregnancy or lactating women
• Use of pharmacologically active weight-loss medications
• Bariatric surgery
• Ketoacidosis, lactic acidosis, hyperosmolar coma
• Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
• Gastro-intestinal (GI) disorders associated with chronic diarrhea
• Congestive heart failure, New York Heart Association (NYHA) class III or IV