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

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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)


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
We found this trial at
1
site
Lincoln, Nebraska 68506
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from
Lincoln, NE
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