Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/27/2016 |
Start Date: | June 2015 |
End Date: | April 2016 |
A Randomized, Double-blind, Placebo-controlled, Parallel Group, 2-part Study Investigating the Effect of LIK066 on Body Weight in Dysglycemic (Prediabetes or Type 2 Diabetes) and Normoglycemic Patients With Elevated Body Mass Index
A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and
normoglycemic patients with elevated body mass index (BMI)
normoglycemic patients with elevated body mass index (BMI)
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
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
Other inclusion/exclusion criteria may apply
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