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

• Status: Completed
• Trial end date: 2018-07-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Licogliflozin

Criteria

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