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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
460
Percent Change From Baseline in Body Weight at 24 Weeks
Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment
Time frame: Baseline, Week 24 (Epoch 3)
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline
Time frame: Baseline, Week 24
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)
Time frame: Baseline, Week 24
Percentage Change From Baseline on Waist Circumference
Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.
Time frame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)
FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).
Time frame: Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)
HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.
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Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
Jasper, Alabama, United States
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Carmichael, California, United States
Novartis Investigative Site
Concord, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Northridge, California, United States
Novartis Investigative Site
Roseville, California, United States
Novartis Investigative Site
San Ramon, California, United States
Novartis Investigative Site
Stockton, California, United States
...and 73 more locations
Time frame: Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured
Time frame: Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)
Change From Baseline in 24-hour Urinary Glucose Excretion
Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.
Time frame: Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)
Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)
Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)
Time frame: Between Week 24 and Week 48 (Epoch 4)
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
Time frame: Baseline, Week 24
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Evaluation of 24-hour urinary calcium after 48 weeks of treatment
Time frame: Baseline, Week 24, Week 48
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment
Time frame: Week 24, Week 48
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment
Time frame: Week 24, Week 48
Change From Baseline in Fasting Lipid Profile (Lipoproteins)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Time frame: Baseline, Week 24, Week 24 to Week 48 (Epoch 4)
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Time frame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Time frame: Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)
Observe maximum plasma concentration following administration of LIK066 (Cmax)
Time frame: Summary at Week 24 from qd or bid regimens
Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)
Time to reach the maximum concentration after administration of LIK066 (Tmax)
Time frame: Summary at Week 24 for qd or bid regimens
Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)
Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)
Time frame: Summary at Week 24 from qd or bid regimens (0-6h)
Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)
Last non-zero concentration area under the curve (AUClast)
Time frame: Summary at Week 24 from qd or bid regimens