A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

• Status: Completed
• Trial end date: 2018-08-02
• Target enrollment: 0
• Participant gender: All

Summary

This was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Licogliflozin

Criteria

Inclusion Criteria:

1. informed consent

2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)

3. willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)

Exclusion Criteria:

• Hypersensitivity to any of the study medications

• Pregnancy or lactating women

• History of malignancies

• Use of pharmacologically active weight loss products

• Bariatric surgery

• Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit.

• HbA1c >10% at the screening visit.