A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults

Phase 2

Completed

• Conditions: Obesity; Overweight
• Interventions: Drug: Placebo; Drug: LIK066

• Registration Number: NCT03100058
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Study Start: 2017-05-06
• Primary Completion: 2018-03-02
• Study Completion: 2018-08-02
• Disposition First Submitted: 2019-01-16
• Disposition First Submitted QC: 2019-01-16
• Disposition First Posted: 2019-01-17
• Results First Submitted: 2019-07-30
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-27
• Last Update Submitted: 2020-01-27
• Results First Posted: 2020-02-06
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. informed consent
2. (BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)
3. willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Epoch 3)	Placebo	Matching placebo tablets for 24 weeks
LIK066 25mg bid (Epoch 3)	LIK066	LIK066 25mg bid (once daily) dosing frequency for 24 weeks
LIK066 2.5mg bid (Epoch 3)	LIK066	LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks
LIK066 5mg bid (Epoch 3)	LIK066	LIK066 5mg bid (once daily) dosing frequency for 24 weeks
LIK066 10mg qd (Epoch 3)	LIK066	LIK066 10mg qd (once daily) dosing frequency for 24 weeks
LIK066 50mg bid (Epoch 3)	LIK066	LIK066 50mg bid dosing frequency for 24 weeks
LIK066 2.5mg qd (Epoch 3)	LIK066	LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.
LIK066 150mg qd (Epoch 3)	LIK066	LIK066 150mg qd (once daily) dosing frequency for 24 weeks
Placebo/Placebo (Epoch 4)	Placebo	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
LIK066 50mg qd (Epoch 3)	LIK066	LIK066 50mg qd (once daily) dosing frequency for 24 weeks
LIK066 qd/LIK066 25mg qd (Epoch 4)	LIK066	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
LIK066 bid/LIK066 35mg qd (Epoch 4)	LIK066	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
Placebo/LIK066 25mg qd (Epoch 4)	LIK066	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

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Body Weight at 24 Weeks	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 Outcome Measures

Name	Time	Method
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion	Baseline, Week 24, Week 48	Evaluation of 24-hour urinary calcium after 48 weeks of treatment
Change From Baseline in Fasting Lipid Profile (Lipoproteins)	Baseline, Week 24, Week 24 to Week 48 (Epoch 4)	Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study	Baseline, Week 24	Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups	Baseline, Week 24	Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)
Percentage Change From Baseline on Waist Circumference	Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)	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.
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)	HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.
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)	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
Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)	Between Week 24 and Week 48 (Epoch 4)	Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion	Baseline, Week 24	Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion	Week 24, Week 48	Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion	Week 24, Week 48	Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment
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)	FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).
Change From Baseline in 24-hour Urinary Glucose Excretion	Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)	Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)	Baseline to Week 24, Week 24 to Week 48 (Epoch 4)	Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
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)	Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)
Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)	Summary at Week 24 for qd or bid regimens	Time to reach the maximum concentration after administration of LIK066 (Tmax)
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)	Baseline to Week 24, Week 24 to Week 48 (Epoch 4)	Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)	Summary at Week 24 from qd or bid regimens	Last non-zero concentration area under the curve (AUClast)
Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)	Summary at Week 24 from qd or bid regimens	Observe maximum plasma concentration following administration of LIK066 (Cmax)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Stevenage, United Kingdom