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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Drug: LIK066 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 6, 2017
Actual Primary Completion Date : March 2, 2018
Actual Study Completion Date : August 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Placebo Comparator: Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Drug: Placebo
Placebo

Experimental: LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Experimental: LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Experimental: LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Experimental: LIK066 2.5mg bid (Epoch 3)
LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Experimental: LIK066 5mg bid (Epoch 3)
LIK066 5mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Experimental: LIK066 25mg bid (Epoch 3)
LIK066 25mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

Experimental: LIK066 50mg bid (Epoch 3)
LIK066 50mg bid dosing frequency for 24 weeks
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

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
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

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
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

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
Drug: LIK066
LIK066 will be supplied in different doses as tablets to be taken orally.

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
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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)

  3. 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.

  4. 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).

  5. 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.

  6. 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

  7. 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.

  8. 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)

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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)

  17. 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)

  18. 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)

  19. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100058


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] September 19, 2017
Statistical Analysis Plan  [PDF] August 15, 2018

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03100058    
Other Study ID Numbers: CLIK066B2201
2016-002868-14 ( EudraCT Number )
First Posted: April 4, 2017    Key Record Dates
Results First Posted: February 6, 2020
Last Update Posted: February 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Obesity
Overweight
Additional relevant MeSH terms:
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Overweight
Body Weight
Licogliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs