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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: LIK066; Drug: Placebo

• Registration Number: NCT03320941
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-22
• Study First Submitted QC: 2017-10-22
• Study First Posted: 2017-10-25
• Study Start: 2017-12-07
• Primary Completion: 2018-07-25
• Study Completion: 2018-07-25
• Results First Submitted: 2019-07-23
• Results First Submitted QC: 2019-09-05
• Results First Posted: 2019-10-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIK066 10 mg	LIK066	Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.
LIK066 25 mg	LIK066	Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.
LIK066 2.5 mg	LIK066	Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.
LIK066 50 mg	LIK066	Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.
Placebo	Placebo	Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Body Weight at Week 12	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 Outcome Measures

Name	Time	Method
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12	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
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)	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.
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)	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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)	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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol	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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)	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
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)	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
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level	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
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)	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
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)	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
Change From Baseline in Uric Acid at Week 12	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
Change From Baseline on Urine Albumin at Week 12	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
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)	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
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)	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
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12	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
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12	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
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12	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
Pharmacokinetics - Plasma Trough Concentrations of LIK066	Week 12	Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Toshima-ku, Tokyo, Japan