Overview

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.