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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320941
• Other study ID #: CLIK066B1201
• Status: Completed
• Phase: Phase 2
• Start date: December 7, 2017
• Est. completion date: July 25, 2018

Study information

• Verified date: September 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 25, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Ageo-city	Saitama
Japan	Novartis Investigative Site	Akashi	Hyogo
Japan	Novartis Investigative Site	Chikushino-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Higashiosaka-city	Osaka
Japan	Novartis Investigative Site	Higashiosaka-city	Osaka
Japan	Novartis Investigative Site	Kakogawa-city	Hyogo
Japan	Novartis Investigative Site	Kawaguchi-City	Saitama
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kumamoto-city	Kumamoto
Japan	Novartis Investigative Site	Kyoto city	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Matsudo city	Chiba
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Nagasaki city	Nagasaki
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Tokorozawa	Saitama
Japan	Novartis Investigative Site	Tokorozawa-city	Saitama
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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.	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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	Baseline, Week 12
Secondary	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).	Week 12

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com