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

Phase 2CompletedNCT03320941

Novartis Pharmaceuticals126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

126

Conditions

Obesity

Interventions

LIK066DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (24)

Novartis Investigative Site

Matsudo, Chiba, Japan

Outcomes

Primary Outcomes

Percentage Change From Baseline in Body Weight at 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.

Time frame: Baseline, Week 12

Secondary Outcomes

Responder Rates According to Percentage Decrease in Body Weight From Baseline to 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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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Novartis Investigative Site

Chikushino-shi, Fukuoka, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Novartis Investigative Site

Akashi, Hyōgo, Japan

Novartis Investigative Site

Kakogawa, Hyōgo, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Kumamoto, Kumamoto, Japan

Novartis Investigative Site

Kumamoto, Kumamoto, Japan

...and 14 more locations

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

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

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

Time frame: Baseline, Week 12

Change From Baseline in Uric Acid at 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

Time frame: Baseline, Week 12

Change From Baseline on Urine Albumin at 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

Time frame: Baseline, Week 12

Change From Baseline on Urine Albumin to Creatinine Ratio at 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

Time frame: Baseline, Week 12

Percent Change From Baseline on Visceral Fat Area (VFA) at 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

Time frame: Baseline, Week 12

Percent Change From Baseline on Subcutaneous Fat Area (SFA) at 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

Time frame: Baseline, Week 12

Pharmacokinetics - Plasma Trough Concentrations of LIK066

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

Time frame: Week 12