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Completed

NCT Number: NCT03320941

A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity

The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to support dose selection for Phase 3 development in Japanese adults with obesity disease.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Matsudo, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
  • BMI ≥ 25 kg/m^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35 kg/m^2 at least one obesity-related comorbidity
  • Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%
  • Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female
  • Visceral fat area ≥ 100 cm^2
  • Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study

Exclusion criteria

  • Pregnancy or lactating women
  • Use of pharmacologically active weight-loss medications
  • Bariatric surgery
  • Ketoacidosis, lactic acidosis, hyperosmolar coma
  • Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to screening
  • Gastro-intestinal (GI) disorders associated with chronic diarrhea
  • Congestive heart failure, New York Heart Association (NYHA) class III or IV

Treatment and study plan

LIK066

Drug

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

Placebo

Drug

Placebo will be supplied as tablets to be taken daily orally.

Primary outcomes

  1. Percentage Change From Baseline in Body Weight at Week 12

    Time frame: Baseline, Week 12

    The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.

Secondary outcomes

  1. Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12

    Time frame: Baseline, Week 12

    The responder rates according to percentage decrease in body weight either ≥ 3%, ≥ 5% or ≥ 10%, from baseline at Week 12, for the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 No Statistical Analysis for >=5% and >=10% was not calculated due to division by zero

  2. Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)

    Time frame: Baseline, Week 12

    The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12.

  3. Change From Baseline at Week 12 on Waist Circumference at Umbilical Level

    Time frame: Baseline, Week 12

    Waist circumference will be measured to the nearest 0.1 cm in a standing position, at the end of a normal expiration, using a tape at the level of umbilicus. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  4. Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 12

    HbA1c will be measured from a blood sample obtained and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  5. Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)

    Time frame: Baseline, Week 12

    FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake) at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  6. Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 12

    After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  7. Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 12

    After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, DBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  8. Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)

    Time frame: Baseline, Week 12

    Fasting lipid profile (Triglycerides (TG)), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  9. Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol

    Time frame: Baseline, Week 12

    Fasting lipid profile (total cholesterol), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  10. Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)

    Time frame: Baseline, Week 12

    Fasting lipid profile (HDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  11. Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)

    Time frame: Baseline, Week 12

    Fasting lipid profile (LDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  12. Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)

    Time frame: Baseline, Week 12

    High sensitivity CRP will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  13. Change From Baseline in Uric Acid at Week 12

    Time frame: Baseline, Week 12

    Uric acid will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  14. Change From Baseline on Urine Albumin at Week 12

    Time frame: Baseline, Week 12

    Urine albumin will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  15. Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12

    Time frame: Baseline, Week 12

    Urine albumin to creatinine ratio will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  16. Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12

    Time frame: Baseline, Week 12

    VFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  17. Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12

    Time frame: Baseline, Week 12

    SFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12

  18. Pharmacokinetics - Plasma Trough Concentrations of LIK066

    Time frame: Week 12

    Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).

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 12 Weeks Treatment With 4 Doses of LIK066 Compared to Placebo in Japanese Patients With Obesity Disease

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2017
Registry last updated
Jun 26, 2024

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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