Overview

Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index

Status:
Completed
Trial end date:
2016-04-04
Target enrollment:
0
Participant gender:
All
Summary
A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Licogliflozin
Criteria
Key Inclusion Criteria:

- Subjects with stable health condition as determined by past medical history, physical
examination, electrocardiogram, and laboratory tests at screening.

- Patients with dysglycemia are patients with: Fasting plasma glucose >100mg/dL (5.6
mmol/L), or HbA1c > 5.7% and < 10% at screening.

- Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.

- If treated with antidiabetic medications (other than prohibited medications), patients
must be on a stable dose for 12 weeks prior to randomization and maintain the dose
until the end of the study.

- Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at
screening, with stable body weight (± 5 kg) within 3 months prior to screening

Key Exclusion Criteria:

- Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or
other chronic medical condition which is considered serious or unstable, other than
stable cardiovascular disease, treated hypertension, dyslipidemia or other stable
chronic disorders

- Clinically significant GI disorder related to malabsorption or that may affect drug or
glucose absorption or history of significant gastrointestinal surgery that could
affect intestinal glucose absorption

- Enrollment in a diet, weight loss or exercise programs with the specific intent of
losing weight, within 3 months prior to randomization, or clinical diagnosis of any
eating disorder

- Pregnant or nursing (lactating) women, and women of child-bearing potential