Clinical trial NCT03320941: A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity disease
Over weight
T2DM
interventional study
Weight loss
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change From Baseline in Body Weight at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
timeFrame: Baseline, Week 12
measure: Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 12
measure: Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
timeFrame: Baseline, Week 12
measure: Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 12
measure: Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
timeFrame: Baseline, Week 12
measure: Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Uric Acid at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline on Urine Albumin at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
timeFrame: Baseline, Week 12
measure: Pharmacokinetics - Plasma Trough Concentrations of LIK066
timeFrame: Week 12
Other outcomes:
Locations:
city: Matsudo city
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Chikushino-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Akashi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kakogawa-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kumamoto City
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kumamoto-city
country: Japan
facility: Novartis Investigative Site
state: Kumamoto
city: Kyoto city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Nagasaki city
country: Japan
facility: Novartis Investigative Site
state: Nagasaki
city: Higashiosaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Higashiosaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Ageo-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Kawaguchi-City
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kiyose-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Yokote K, Sano M, Tsumiyama I, Keefe D. Dose-dependent reduction in body weight with LIK066 (licogliflozin) treatment in Japanese patients with obesity. Diabetes Obes Metab. 2020 Jul;22(7):1102-1110. doi: 10.1111/dom.14006. Epub 2020 Mar 12.