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

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ClinicalTrials.gov Identifier: NCT03100058
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 3, 2017
First Posted Date  ICMJE April 4, 2017
Results First Submitted Date  ICMJE July 30, 2019
Results First Posted Date  ICMJE February 6, 2020
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE May 6, 2017
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2020)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)		 Percent change from baseline in body weight at 24 weeks [ Time Frame: baseline, week 24 ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2020)
  • Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM) [ Time Frame: 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 Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM) [ Time Frame: 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) [ Time Frame: 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
  • Change From Baseline in 24-hour Urinary Glucose Excretion [ Time Frame: 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.
  • Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4) [ Time Frame: 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 [ Time Frame: Baseline, Week 24 ]
    Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
  • Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion [ Time Frame: Baseline, Week 24, Week 48 ]
    Evaluation of 24-hour urinary calcium after 48 weeks of treatment
  • Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion [ Time Frame: 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 [ Time Frame: Week 24, Week 48 ]
    Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment
  • Change From Baseline in Fasting Lipid Profile (Lipoproteins) [ Time Frame: 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
  • Change From Baseline in High Sensitive C-reactive Protein (hsCRP) [ Time Frame: 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
  • Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol) [ Time Frame: 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: Observe Maximum Plasma Concentration (Cmax) [ Time Frame: Summary at Week 24 from qd or bid regimens ]
    Observe maximum plasma concentration following administration of LIK066 (Cmax)
  • Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax) [ Time Frame: Summary at Week 24 for qd or bid regimens ]
    Time to reach the maximum concentration after administration of LIK066 (Tmax)
  • Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t) [ Time Frame: 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: Last Non-zero Concentration Area Under the Curve (AUClast) [ Time Frame: Summary at Week 24 from qd or bid regimens ]
    Last non-zero concentration area under the curve (AUClast)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Number of subjects with response rate according to percent decrease in body weight [ Time Frame: baseline, week 24 ]
    Responder rates according to percent decrease in body weight either ≥ 5 % or ≥ 10 % from baseline.
  • Number of subjects with response rate according to percent decrease in body weight by subgroup [ Time Frame: baseline, week 24 ]
    Dose-response relationship for weight loss
  • Change from baseline on waist circumference [ Time Frame: baseline, week 24, week 48 ]
    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) [ Time Frame: baseline, week 24, week 48 ]
    HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: baseline, week 24, week 48 ]
    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 mean sitting systolic blood pressure (msSBP) and mean sitting diastolic blood pressure (msDBP) [ Time Frame: baseline, Week 24, Week 48 ]
    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 three times using the automatic BP monitor and an appropriate size cuff. All 3 sitting BP readings will be used for evaluation of mean sitting SBP and DBP
  • Change from baseline in 24-hour urinary glucose excretion [ Time Frame: baseline, week 24, week 48 ]
    Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.
  • Change in weight in the overall population and by subgroups [ Time Frame: baseline, week 24, week 48 ]
    Change in weight from baseline to week 24 and 48 in the overall population and by subgroups will be reported.
  • 24-hour urinary calcium and phosphorus excretion [ Time Frame: week 24, week 48 ]
    24-hour urinary calcium and phosphorus excretion (mg/dL) will be reported in this endpoint.
  • Pharmacokinetics of LIK066: Area under the plasma concentration-time curve from time zero time 't' (AUC0-t) [ Time Frame: Baseline, 0 hour (pre-dose) and approximately 1 hour, 2 hours, 4 hours and 6 hours post dose on week 12, 24 and 34 ]
    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: Observe maximum plasma concentration (cmax) [ Time Frame: Baseline, 0 hour (pre-dose) and approximately 1 hour, 2 hours, 4 hours and 6 hours post dose on week 12, 24 and 34 ]
    Observe maximum plasma concentration following administration of LIK066 (Cmax)
  • Pharmacokinetics of LIK066: Time to reach the maximum concentration (Tmax) [ Time Frame: Baseline, 0 hour (pre-dose) and approximately 1 hour, 2 hours, 4 hours and 6 hours post dose on week 12, 24 and 34 ]
    Time to reach the maximum concentration after administration of LIK066 (Tmax)
  • Pharmacokinetics of LIK066: Last non-zero concentration area under the curve (AUClast) [ Time Frame: Baseline, 0 hour (pre-dose) and approximately 1 hour, 2 hours, 4 hours and 6 hours post dose on week 12, 24 and 34 ]
    Last non-zero concentration area under the curve (AUClast)
  • Change from baseline in fasting lipid profile (triglycerides/cholesterol) [ Time Frame: baseline, week 24, week 48 ]
  • Change from baseline in fasting lipid profile (lipoproteins) [ Time Frame: baseline, week 24, week 48 ]
  • Change from baseline in High sensitive C-reactive protein (hsCRP) [ Time Frame: baseline, week 24, week 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Drug: LIK066
    LIK066 will be supplied in different doses as tablets to be taken orally.
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: LIK066 2.5mg qd (Epoch 3)
    LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.
    Intervention: Drug: LIK066
  • Placebo Comparator: Placebo (Epoch 3)
    Matching placebo tablets for 24 weeks
    Intervention: Drug: Placebo
  • Experimental: LIK066 10mg qd (Epoch 3)
    LIK066 10mg qd (once daily) dosing frequency for 24 weeks
    Intervention: Drug: LIK066
  • Experimental: LIK066 50mg qd (Epoch 3)
    LIK066 50mg qd (once daily) dosing frequency for 24 weeks
    Intervention: Drug: LIK066
  • Experimental: LIK066 150mg qd (Epoch 3)
    LIK066 150mg qd (once daily) dosing frequency for 24 weeks
    Intervention: Drug: LIK066
  • Experimental: LIK066 2.5mg bid (Epoch 3)
    LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks
    Intervention: Drug: LIK066
  • Experimental: LIK066 5mg bid (Epoch 3)
    LIK066 5mg bid (once daily) dosing frequency for 24 weeks
    Intervention: Drug: LIK066
  • Experimental: LIK066 25mg bid (Epoch 3)
    LIK066 25mg bid (once daily) dosing frequency for 24 weeks
    Intervention: Drug: LIK066
  • Experimental: LIK066 50mg bid (Epoch 3)
    LIK066 50mg bid dosing frequency for 24 weeks
    Intervention: Drug: LIK066
  • Experimental: 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: Drug: LIK066
  • Experimental: 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: Drug: LIK066
  • Experimental: 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: Drug: LIK066
  • Placebo Comparator: 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: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2017)		 460
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)		 432
Actual Study Completion Date  ICMJE August 2, 2018
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Czechia,   Hungary,   Slovakia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03100058
Other Study ID Numbers  ICMJE CLIK066B2201
2016-002868-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP