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Completed

NCT Number: NCT03100058

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIK066

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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