A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 24 Weeks Treatment With 8 Doses of LIK066 Compared to Placebo in Obese or Overweight Adults, Followed by 24 Weeks Treatment With 2 Doses of LIK066 and Placebo
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 460
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline in Body Weight at 24 Weeks
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •informed consent
- •(BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)
- •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.
Arms & Interventions
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.
Intervention: LIK066 (Drug)
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Intervention: Placebo (Drug)
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
Intervention: LIK066 (Drug)
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
Intervention: LIK066 (Drug)
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
Intervention: LIK066 (Drug)
LIK066 2.5mg bid (Epoch 3)
LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks
Intervention: LIK066 (Drug)
LIK066 5mg bid (Epoch 3)
LIK066 5mg bid (once daily) dosing frequency for 24 weeks
Intervention: LIK066 (Drug)
LIK066 25mg bid (Epoch 3)
LIK066 25mg bid (once daily) dosing frequency for 24 weeks
Intervention: LIK066 (Drug)
LIK066 50mg bid (Epoch 3)
LIK066 50mg bid dosing frequency for 24 weeks
Intervention: LIK066 (Drug)
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Intervention: LIK066 (Drug)
LIK066 bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Intervention: LIK066 (Drug)
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Intervention: LIK066 (Drug)
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Body Weight at 24 Weeks
Time Frame: Baseline, Week 24 (Epoch 3)
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
Secondary Outcomes
- Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion(Baseline, Week 24, Week 48)
- Change From Baseline in Fasting Lipid Profile (Lipoproteins)(Baseline, Week 24, Week 24 to Week 48 (Epoch 4))
- Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study(Baseline, Week 24)
- Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups(Baseline, Week 24)
- Percentage Change From Baseline on Waist Circumference(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)(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)(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 Week 24 and Week 48 (Epoch 4))
- Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion(Baseline, Week 24)
- Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion(Week 24, Week 48)
- Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion(Week 24, Week 48)
- Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)(Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4))
- Change From Baseline in 24-hour Urinary Glucose Excretion(Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4))
- Change From Baseline in High Sensitive C-reactive Protein (hsCRP)(Baseline to Week 24, Week 24 to Week 48 (Epoch 4))
- Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)(Summary at Week 24 from qd or bid regimens (0-6h))
- Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)(Summary at Week 24 for qd or bid regimens)
- Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)(Baseline to Week 24, Week 24 to Week 48 (Epoch 4))
- Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)(Summary at Week 24 from qd or bid regimens)
- Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)(Summary at Week 24 from qd or bid regimens)