Adults 20 to 75, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage Change From Baseline in Body Weight at Week 12Primary· 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.
Group
Value
95% CI
LIK066 2.5mg qd
-1.86
-2.59 – -0.67
LIK066 10mg qd
-2.84
-3.79 – -2.16
LIK066 25 mg qd
-3.41
-3.96 – -2.84
LIK066 50 mg qd
-3.80
-4.48 – -3.17
Placebo
0.11
-0.90 – 0.97
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12Secondary· 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
>= 3%
Group
Value
95% CI
LIK066 2.5mg qd
15.8
LIK066 10mg qd
55.6
LIK066 25 mg qd
50.0
LIK066 50 mg qd
56.7
Placebo
7.1
>= 5%
Group
Value
95% CI
LIK066 2.5mg qd
5.3
LIK066 10mg qd
27.8
LIK066 25 mg qd
17.9
LIK066 50 mg qd
26.7
Placebo
0.0
>= 10%
Group
Value
95% CI
LIK066 2.5mg qd
0.0
LIK066 10mg qd
0.0
LIK066 25 mg qd
0.0
LIK066 50 mg qd
3.3
Placebo
0.0
>= 3% (Dysglycemic)
Group
Value
95% CI
LIK066 2.5mg qd
12.5
LIK066 10mg qd
75.0
LIK066 25 mg qd
38.5
LIK066 50 mg qd
46.2
Placebo
7.7
>= 5% (Dysglycemic)
Group
Value
95% CI
LIK066 2.5mg qd
0.0
LIK066 10mg qd
62.5
LIK066 25 mg qd
23.1
LIK066 50 mg qd
23.1
Placebo
0.0
>= 10% (Dysglycemic)
Group
Value
95% CI
LIK066 2.5mg qd
0.0
LIK066 10mg qd
0.0
LIK066 25 mg qd
0.0
LIK066 50 mg qd
0.0
Placebo
0.0
>= 3% (T2DM)
Group
Value
95% CI
LIK066 2.5mg qd
18.2
LIK066 10mg qd
40.0
LIK066 25 mg qd
60.0
LIK066 50 mg qd
64.7
Placebo
6.7
>= 5% (T2DM)
Group
Value
95% CI
LIK066 2.5mg qd
9.1
LIK066 10mg qd
0.00
LIK066 25 mg qd
13.3
LIK066 50 mg qd
29.4
Placebo
0.00
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)Secondary· 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.
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-1.90
-3.17 – -0.37
LIK066 10mg qd
-2.95
-3.95 – -2.15
LIK066 25 mg qd
-3.29
-4.19 – -2.57
LIK066 50 mg qd
-3.47
-4.31 – -2.54
Placebo
0.00
-1.25 – 1.19
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
-1.64
-2.54 – -0.26
LIK066 10mg qd
-2.66
-3.49 – -1.16
LIK066 25 mg qd
-3.42
-4.30 – -2.42
LIK066 50 mg qd
-4.23
-5.63 – -3.27
Placebo
0.10
-1.40 – 1.48
Change From Baseline at Week 12 on Waist Circumference at Umbilical LevelSecondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
-2.47
-4.003 – -0.937
LIK066 10mg qd
-2.63
-4.172 – -1.082
LIK066 25 mg qd
-2.65
-3.907 – -1.393
LIK066 50 mg qd
-3.11
-4.320 – -1.895
Placebo
-1.37
-2.636 – -0.100
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-2.78
-5.187 – -0.368
LIK066 10mg qd
-4.49
-6.856 – -2.123
LIK066 25 mg qd
-2.08
-3.977 – -0.177
LIK066 50 mg qd
-2.23
-4.123 – -0.333
Placebo
-0.41
-2.312 – 1.483
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
-2.22
-4.156 – -0.283
LIK066 10mg qd
-1.39
-3.418 – 0.631
LIK066 25 mg qd
-2.90
-4.557 – -1.244
LIK066 50 mg qd
-3.88
-5.416 – -2.340
Placebo
-2.19
-3.859 – -0.520
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)Secondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
-0.285
-0.415 – -0.155
LIK066 10mg qd
-0.355
-0.488 – -0.223
LIK066 25 mg qd
-0.366
-0.473 – -0.259
LIK066 50 mg qd
-0.418
-0.521 – -0.314
Placebo
-0.079
-0.187 – 0.028
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-0.139
-0.261 – -0.016
LIK066 10mg qd
-0.184
-0.306 – -0.062
LIK066 25 mg qd
-0.196
-0.292 – -0.101
LIK066 50 mg qd
-0.163
-0.259 – -0.067
Placebo
-0.050
-0.146 – 0.046
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
-0.405
-0.616 – -0.195
LIK066 10mg qd
-0.491
-0.708 – -0.275
LIK066 25 mg qd
-0.502
-0.679 – -0.325
LIK066 50 mg qd
-0.618
-0.784 – -0.452
Placebo
-0.093
-0.271 – 0.086
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)Secondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
-0.334
-0.652 – -0.016
LIK066 10mg qd
-0.665
-0.990 – -0.340
LIK066 25 mg qd
-0.747
-1.007 – -0.486
LIK066 50 mg qd
-0.986
-1.238 – -0.733
Placebo
-0.160
-0.423 – 0.103
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
0.002
-0.322 – 0.326
LIK066 10mg qd
-0.126
-0.453 – 0.200
LIK066 25 mg qd
-0.262
-0.515 – -0.008
LIK066 50 mg qd
-0.472
-0.728 – -0.217
Placebo
-0.217
-0.471 – 0.038
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
-0.606
-1.095 – -0.118
LIK066 10mg qd
-1.111
-1.619 – -0.604
LIK066 25 mg qd
-1.145
-1.559 – -0.730
LIK066 50 mg qd
-1.377
-1.766 – -0.988
Placebo
-0.079
-0.497 – 0.339
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)Secondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
-4.90
-9.049 – -0.746
LIK066 10mg qd
-5.12
-9.403 – -0.834
LIK066 25 mg qd
-6.36
-9.781 – -2.935
LIK066 50 mg qd
-6.94
-10.233 – -3.655
Placebo
-5.36
-8.758 – -1.961
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-5.79
-12.457 – 0.883
LIK066 10mg qd
-7.10
-13.825 – -0.369
LIK066 25 mg qd
-3.58
-8.811 – 1.657
LIK066 50 mg qd
-4.17
-9.399 – 1.051
Placebo
-7.09
-12.294 – -1.891
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
-4.16
-9.414 – 1.091
LIK066 10mg qd
-2.96
-8.500 – 2.588
LIK066 25 mg qd
-8.63
-13.143 – -4.120
LIK066 50 mg qd
-9.00
-13.182 – -4.810
Placebo
-3.77
-8.255 – 0.724
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)Secondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
-3.72
-6.803 – -0.627
LIK066 10mg qd
-3.54
-6.700 – -0.377
LIK066 25 mg qd
-4.36
-6.892 – -1.818
LIK066 50 mg qd
-5.23
-7.677 – -2.788
Placebo
-3.12
-5.647 – -0.597
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-3.32
-8.404 – 1.769
LIK066 10mg qd
-4.40
-9.490 – 0.699
LIK066 25 mg qd
-2.46
-6.441 – 1.513
LIK066 50 mg qd
-4.25
-8.230 – -0.279
Placebo
-4.31
-8.257 – -0.357
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
-4.00
-7.943 – -0.059
LIK066 10mg qd
-2.45
-6.584 – 1.687
LIK066 25 mg qd
-5.98
-9.352 – -2.607
LIK066 50 mg qd
-5.92
-9.066 – -2.776
Placebo
-1.93
-5.303 – 1.448
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)Secondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
1.840
-30.956 – 34.636
LIK066 10mg qd
11.057
-22.372 – 44.487
LIK066 25 mg qd
43.928
17.118 – 70.737
LIK066 50 mg qd
5.307
-20.648 – 31.261
Placebo
17.401
-9.474 – 44.275
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-1.153
-62.637 – 60.331
LIK066 10mg qd
-1.986
-64.104 – 60.132
LIK066 25 mg qd
52.284
3.839 – 100.729
LIK066 50 mg qd
14.061
-34.625 – 62.746
Placebo
20.962
-27.416 – 69.340
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
1.016
-36.069 – 38.100
LIK066 10mg qd
23.108
-14.937 – 61.153
LIK066 25 mg qd
34.747
3.600 – 65.893
LIK066 50 mg qd
-0.057
-29.478 – 29.363
Placebo
13.806
-17.085 – 44.697
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total CholesterolSecondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
-1.290
-6.809 – 4.229
LIK066 10mg qd
-2.983
-8.711 – 2.745
LIK066 25 mg qd
0.884
-3.663 – 5.430
LIK066 50 mg qd
0.302
-4.096 – 4.700
Placebo
-2.244
-6.800 – 2.312
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-3.055
-12.284 – 6.173
LIK066 10mg qd
-6.017
-15.916 – 3.882
LIK066 25 mg qd
4.273
-3.085 – 11.630
LIK066 50 mg qd
-1.734
-9.000 – 5.532
Placebo
-3.559
-10.940 – 3.822
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
0.158
-6.814 – 7.129
LIK066 10mg qd
-1.367
-8.670 – 5.937
LIK066 25 mg qd
-1.646
-7.772 – 4.481
LIK066 50 mg qd
1.817
-3.857 – 7.491
Placebo
-0.671
-6.635 – 5.294
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)Secondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
1.499
-3.683 – 6.682
LIK066 10mg qd
-2.461
-7.790 – 2.868
LIK066 25 mg qd
-5.253
-9.514 – -0.993
LIK066 50 mg qd
0.112
-4.014 – 4.237
Placebo
-3.454
-7.739 – 0.830
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-0.519
-9.144 – 8.107
LIK066 10mg qd
0.329
-8.368 – 9.027
LIK066 25 mg qd
-3.279
-10.056 – 3.498
LIK066 50 mg qd
-0.147
-6.917 – 6.622
Placebo
-4.329
-11.096 – 2.437
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
2.886
-3.774 – 9.545
LIK066 10mg qd
-4.696
-11.654 – 2.261
LIK066 25 mg qd
-6.993
-12.672 – -1.315
LIK066 50 mg qd
0.235
-5.133 – 5.604
Placebo
-2.677
-8.484 – 3.130
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)Secondary· 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
Overall Study
Group
Value
95% CI
LIK066 2.5mg qd
0.757
-7.220 – 8.734
LIK066 10mg qd
-2.363
-10.702 – 5.975
LIK066 25 mg qd
0.037
-6.524 – 6.598
LIK066 50 mg qd
4.726
-1.616 – 11.068
Placebo
-0.552
-7.154 – 6.051
Dysglycemic
Group
Value
95% CI
LIK066 2.5mg qd
-3.065
-16.507 – 10.376
LIK066 10mg qd
-4.473
-18.904 – 9.958
LIK066 25 mg qd
2.579
-8.102 – 13.259
LIK066 50 mg qd
2.128
-8.426 – 12.681
Placebo
-3.994
-14.722 – 6.735
T2DM
Group
Value
95% CI
LIK066 2.5mg qd
3.727
-6.379 – 13.833
LIK066 10mg qd
-1.562
-12.127 – 9.004
LIK066 25 mg qd
-1.295
-10.099 – 7.510
LIK066 50 mg qd
6.803
-1.311 – 14.917
Placebo
2.942
-5.699 – 11.584
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected till the end of the study.(about 12 weeks) and serious adverse events (SAEs) were collected until 30 days after the last study visit (12 weeks + 30 days = about 114 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03205150 — Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients
· Phase 2
· completed
NCT03152552 — A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabete
· Phase 2
· terminated
NCT03152591 — Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
· Phase 2
· completed
NCT03198767 — Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
· Phase 2
· completed
NCT03100058 — A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 26 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03320941.