Phase 2
Completed N=126
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
Source: ClinicalTrials.gov NCT03320941 ↗Enrolled (actual)
126
Serious AEs
0.8%
Results posted
Oct 2019
Primary outcomePrimary: Percentage Change From Baseline in Body Weight at Week 12 — -1.86; -2.84; -3.41; -3.80 Percent Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Body Weight at Week 12 |
-1.86; -2.84; -3.41; -3.80; 0.11 | — |
| SECONDARY Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12 |
15.8; 55.6; 50.0; 56.7; 7.1; 5.3 | 0.390 |
| SECONDARY Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM) |
-1.90; -2.95; -3.29; -3.47; 0.00; -1.64 | — |
| SECONDARY Change From Baseline at Week 12 on Waist Circumference at Umbilical Level |
-2.47; -2.63; -2.65; -3.11; -1.37; -2.78 | 0.278 |
| SECONDARY Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c) |
-0.285; -0.355; -0.366; -0.418; -0.079; -0.139 | 0.018 sig |
| SECONDARY Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG) |
-0.334; -0.665; -0.747; -0.986; -0.160; 0.002 | 0.408 |
| SECONDARY Change From Baseline at Week 12 on Systolic Blood Pressure (SBP) |
-4.90; -5.12; -6.36; -6.94; -5.36; -5.79 | 0.865 |
| SECONDARY Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP) |
-3.72; -3.54; -4.36; -5.23; -3.12; -3.32 | 0.769 |
| SECONDARY Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG) |
1.840; 11.057; 43.928; 5.307; 17.401; -1.153 | 0.470 |
| SECONDARY Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol |
-1.290; -2.983; 0.884; 0.302; -2.244; -3.055 | 0.792 |
| SECONDARY Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL) |
1.499; -2.461; -5.253; 0.112; -3.454; -0.519 | 0.148 |
| SECONDARY Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL) |
0.757; -2.363; 0.037; 4.726; -0.552; -3.065 | 0.802 |
| SECONDARY Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP) |
-48.448; 69.004; -24.207; -55.536; -93.268; 16.582 | 0.625 |
| SECONDARY Change From Baseline in Uric Acid at Week 12 |
-52.6; -55.2; -58.4; -62.0; 12.4; -74.9 | <0.001 sig |
| SECONDARY Change From Baseline on Urine Albumin at Week 12 |
-1.838; 0.008; -3.902; -3.099; -1.282; -1.941 | 0.764 |
| SECONDARY Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12 |
-0.849; -0.848; -2.552; -1.878; -1.504; -0.553 | 0.572 |
| SECONDARY Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12 |
-4.139; -5.832; -9.185; -11.352; -3.949; -1.532 | 0.968 |
| SECONDARY Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12 |
-6.562; -4.454; -7.983; -5.745; -3.477; -7.745 | 0.278 |
| SECONDARY Pharmacokinetics - Plasma Trough Concentrations of LIK066 |
1.63; 4.17; 12.8; 26.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT03320941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.