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CompletedNCT03320941Updated Jun 26, 2024Results posted

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

A Phase 2 interventional study of LIK066 and Placebo in Obesity, sponsored by Novartis Pharmaceuticals. Completed at 24 sites in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Obesity by Novartis Pharmaceuticals — none open to participants now, none under way, none of them phase 3. Obesity · Novartis Pharmaceuticals.

Enrollment
4th of 13
126 · median 107
Started
2017
with 6 others
Phase 2
9 of 13
none open now
Registered
10th of 13
by date

Among the 13 studies in Obesity by Novartis Pharmaceuticals, this one is the 4th largest by enrollment, is one of 7 that started in 2017, is one of 9 in phase 2, and was the 10th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

None of the 13 studies in Obesity by Novartis Pharmaceuticals is open now.

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 20 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 13 studies in Obesity by Novartis Pharmaceuticals as a file.
02

Study 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.

03

Conditions studied

  • Obesity

Keywords

  • Obesity disease
  • Over weight
  • T2DM
  • interventional study
  • Weight loss
04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with obesity disease and inadequately controlled body weight with diet and/or exercise
  • ≥ 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% ≤ ≤ 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

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, (NYHA) class III or IV
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
126 participants (actual)

Study arms

  • Experimental
    LIK066 2.5 mg

    Eligible patients randomized to this arm will receive LIK066 2.5 mg orally daily for 12 weeks.

    Drug: LIK066

  • Experimental
    LIK066 10 mg

    Eligible patients randomized to this arm will receive LIK066 10 mg orally daily for 12 weeks.

    Drug: LIK066

  • Experimental
    LIK066 25 mg

    Eligible patients randomized to this arm will receive LIK066 25 mg orally daily for 12 weeks.

    Drug: LIK066

  • Experimental
    LIK066 50 mg

    Eligible patients randomized to this arm will receive LIK066 50 mg orally daily for 12 weeks.

    Drug: LIK066

  • Placebo comparator
    Placebo

    Eligible patient randomized to this arm will receive LIK066 matching placebo orally daily for 12 weeks.

    Drug: Placebo

Interventions

  • DrugLIK066

    LIK066 will be supplied in different doses as tablets to be taken orally daily.

  • DrugPlacebo

    Placebo will be supplied as tablets to be taken daily orally.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. 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

    Time frame: Baseline, Week 12

  2. 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.

    Time frame: Baseline, Week 12

  3. 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

    Time frame: Baseline, Week 12

  4. 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

    Time frame: Baseline, Week 12

  5. 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

    Time frame: Baseline, Week 12

  6. 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

    Time frame: Baseline, Week 12

  7. 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

    Time frame: Baseline, Week 12

  8. 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

    Time frame: Baseline, Week 12

  9. 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

    Time frame: Baseline, Week 12

  10. 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

    Time frame: Baseline, Week 12

  11. 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

    Time frame: Baseline, Week 12

  12. 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

    Time frame: Baseline, Week 12

  13. 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

    Time frame: Baseline, Week 12

  14. 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

    Time frame: Baseline, Week 12

  15. 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

    Time frame: Baseline, Week 12

  16. 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

    Time frame: Baseline, Week 12

  17. 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

    Time frame: Baseline, Week 12

  18. 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).

    Time frame: Week 12

07

Results

Posted Oct 2, 2019

Participant flow

126 participants were randomized and received at least one dose of study drug.

Participant flow — Overall Study
MilestoneLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Started1919283129
Completed1919283029
Not completed00010
Withdrew: Subject/guardian decision00010

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline, Week 12
Reported as:
Number · Percent Change
Percentage Change From Baseline in Body Weight at Week 12
Percent ChangeLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Percentage Change From Baseline in Body Weight at Week 12-1.86 (-2.59 to -0.67)-2.84 (-3.79 to -2.16)-3.41 (-3.96 to -2.84)-3.80 (-4.48 to -3.17)0.11 (-0.90 to 0.97)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · Mean difference (net): -1.99 · 95% CI -2.92 to -0.21
  • LIK066 10mg qd vs Placebo · Mean difference (net): -3.00 · 95% CI -4.15 to -1.70
  • LIK066 25 mg qd vs Placebo · Mean difference (net): -3.54 · 95% CI -4.54 to -2.26
  • LIK066 50 mg qd vs Placebo · Mean difference (net): -3.91 · 95% CI -5.01 to -2.77
SecondaryResponder 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

Time frame:
Baseline, Week 12
Reported as:
Number · Percentage of Participants
Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12
Percentage of ParticipantsLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
>= 3%15.855.650.056.77.1
>= 5%5.327.817.926.70.0
>= 10%0.00.00.03.30.0
>= 3% (Dysglycemic)12.575.038.546.27.7
>= 5% (Dysglycemic)0.062.523.123.10.0
>= 10% (Dysglycemic)0.00.00.00.00.0
>= 3% (T2DM)18.240.060.064.76.7
>= 5% (T2DM)9.10.0013.329.40.00
>= 10% (T2DM)0.000.000.005.90.00
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · Regression, Logistic · p = 0.390 · Odds ratio (or): 2.299 · 95% CI 0.344 to 15.350
  • LIK066 10mg qd vs Placebo · Regression, Logistic · p = 0.002 · Odds ratio (or): 15.780 · 95% CI 2.844 to 87.552
  • LIK066 25 mg qd vs Placebo · Regression, Logistic · p = 0.002 · Odds ratio (or): 12.708 · 95% CI 2.511 to 64.320
  • LIK066 50 mg qd vs Placebo · Regression, Logistic · p = <0.001 · Odds ratio (or): 16.813 · 95% CI 3.362 to 84.085
  • LIK066 2.5mg qd vs Placebo · Regression, Logistic · p = 0.727 · Odds ratio (or): 1.697 · 95% CI 0.087 to 33.006
  • LIK066 10mg qd vs Placebo · Regression, Logistic · p = 0.012 · Odds ratio (or): 28.260 · 95% CI 2.066 to 386.473
  • LIK066 25 mg qd vs Placebo · Regression, Logistic · p = 0.059 · Odds ratio (or): 10.333 · 95% CI 0.914 to 116.820
  • LIK066 50 mg qd vs Placebo · Regression, Logistic · p = 0.062 · Odds ratio (or): 9.456 · 95% CI 0.891 to 100.292
  • LIK066 2.5mg qd vs Placebo · Regression, Logistic · p = 0.336 · Odds ratio (or): 3.590 · 95% CI 0.265 to 48.552
  • LIK066 10mg qd vs Placebo · Regression, Logistic · p = 0.075 · Odds ratio, log: 9.112 · 95% CI 0.799 to 103.872
  • LIK066 25 mg qd vs Placebo · Regression, Logistic · p = 0.006 · Odds ratio (or): 29.312 · 95% CI 2.665 to 322.412
  • LIK066 50 mg qd vs Placebo · Regression, Logistic · p = 0.003 · Odds ratio (or): 37.949 · 95% CI 3.477 to 414.232
SecondaryPercentage 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.

Time frame:
Baseline, Week 12
Reported as:
Number · percentage change
Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)
percentage changeLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Dysglycemic-1.90 (-3.17 to -0.37)-2.95 (-3.95 to -2.15)-3.29 (-4.19 to -2.57)-3.47 (-4.31 to -2.54)0.00 (-1.25 to 1.19)
T2DM-1.64 (-2.54 to -0.26)-2.66 (-3.49 to -1.16)-3.42 (-4.30 to -2.42)-4.23 (-5.63 to -3.27)0.10 (-1.40 to 1.48)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · Median difference (final values): -1.84 · 95% CI -3.56 to -0.19
  • LIK066 10mg qd vs Placebo · Mean difference (final values): -2.98 · 95% CI -4.56 to -1.46
  • LIK066 25 mg qd vs Placebo · Mean difference (final values): -3.33 · 95% CI -4.71 to -1.82
  • LIK066 50 mg qd vs Placebo · Mean difference (final values): -3.51 · 95% CI -4.93 to -1.74
  • LIK066 2.5mg qd vs Placebo · Mean difference (final values): -1.96 · 95% CI -3.12 to -0.15
  • LIK066 10mg qd vs Placebo · Mean difference (final values): -2.88 · 95% CI -4.37 to -0.61
  • LIK066 25 mg qd vs Placebo · Mean difference (final values): -3.64 · 95% CI -5.20 to -1.52
  • LIK066 50 mg qd vs Placebo · Median difference (final values): -4.37 · 95% CI -5.93 to -2.79
SecondaryChange 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

Time frame:
Baseline, Week 12
Reported as:
Mean · cm
Change From Baseline at Week 12 on Waist Circumference at Umbilical Level
cmLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-2.47 (-4.003 to -0.937)-2.63 (-4.172 to -1.082)-2.65 (-3.907 to -1.393)-3.11 (-4.320 to -1.895)-1.37 (-2.636 to -0.100)
Dysglycemic-2.78 (-5.187 to -0.368)-4.49 (-6.856 to -2.123)-2.08 (-3.977 to -0.177)-2.23 (-4.123 to -0.333)-0.41 (-2.312 to 1.483)
T2DM-2.22 (-4.156 to -0.283)-1.39 (-3.418 to 0.631)-2.90 (-4.557 to -1.244)-3.88 (-5.416 to -2.340)-2.19 (-3.859 to -0.520)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.278 · Mean difference (final values): -1.10 · 95% CI -3.104 to 0.900
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.216 · Mean difference (final values): -1.26 · 95% CI -3.265 to 0.747
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.158 · Mean difference (final values): -1.28 · 95% CI -3.069 to 0.504
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.053 · Mean difference (final values): -1.74 · 95% CI -3.401 to 0.022
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.130 · Mean difference (final values): -2.36 · 95% CI -5.444 to 0.717
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.011 · Mean difference (final values): -4.08 · 95% CI -7.156 to -0.994
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.215 · Mean difference (final values): -1.66 · 95% CI -4.322 to 0.996
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.184 · Mean difference (final values): -1.81 · 95% CI -4.515 to 0.888
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.982 · Mean difference (final values): -0.03 · 95% CI -2.611 to 2.552
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.544 · Mean difference (final values): 0.80 · 95% CI -1.809 to 3.401
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.552 · Mean difference (final values): -0.71 · 95% CI -3.084 to 1.663
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.143 · Mean difference (final values): -1.69 · 95% CI -3.964 to 0.588
SecondaryPercentage 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percentage
Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)
PercentageLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-0.285 (-0.415 to -0.155)-0.355 (-0.488 to -0.223)-0.366 (-0.473 to -0.259)-0.418 (-0.521 to -0.314)-0.079 (-0.187 to 0.028)
Dysglycemic-0.139 (-0.261 to -0.016)-0.184 (-0.306 to -0.062)-0.196 (-0.292 to -0.101)-0.163 (-0.259 to -0.067)-0.050 (-0.146 to 0.046)
T2DM-0.405 (-0.616 to -0.195)-0.491 (-0.708 to -0.275)-0.502 (-0.679 to -0.325)-0.618 (-0.784 to -0.452)-0.093 (-0.271 to 0.086)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.018 · Mean difference (final values): -0.206 · 95% CI -0.376 to -0.035
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.002 · Mean difference (final values): -0.276 · 95% CI -0.447 to -0.105
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -0.287 · 95% CI -0.437 to -0.136
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -0.338 · 95% CI -0.486 to -0.190
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.258 · Mean difference (final values): -0.089 · 95% CI -0.245 to 0.067
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.088 · Mean difference (final values): -0.134 · 95% CI -0.290 to 0.021
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.035 · Mean difference (final values): -0.146 · 95% CI -0.282 to -0.011
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.100 · Mean difference (final values): -0.113 · 95% CI -0.248 to 0.022
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.029 · Mean difference (final values): -0.313 · 95% CI -0.592 to -0.033
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.006 · Mean difference (final values): -0.399 · 95% CI -0.681 to -0.117
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.002 · Mean difference (final values): -0.409 · 95% CI -0.660 to -0.159
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -0.526 · 95% CI -0.769 to -0.282
SecondaryChange 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

Time frame:
Baseline, Week 12
Reported as:
Mean · mmol/L
Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)
mmol/LLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-0.334 (-0.652 to -0.016)-0.665 (-0.990 to -0.340)-0.747 (-1.007 to -0.486)-0.986 (-1.238 to -0.733)-0.160 (-0.423 to 0.103)
Dysglycemic0.002 (-0.322 to 0.326)-0.126 (-0.453 to 0.200)-0.262 (-0.515 to -0.008)-0.472 (-0.728 to -0.217)-0.217 (-0.471 to 0.038)
T2DM-0.606 (-1.095 to -0.118)-1.111 (-1.619 to -0.604)-1.145 (-1.559 to -0.730)-1.377 (-1.766 to -0.988)-0.079 (-0.497 to 0.339)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.408 · Mean difference (final values): -0.174 · 95% CI -0.589 to 0.241
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.018 · Mean difference (final values): -0.505 · 95% CI -0.924 to -0.087
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.002 · Mean difference (final values): -0.587 · 95% CI -0.956 to -0.217
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -0.826 · 95% CI -1.188 to -0.463
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.293 · Mean difference (final values): 0.218 · 95% CI -0.194 to 0.631
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.665 · Mean difference (final values): 0.090 · 95% CI -0.325 to 0.506
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.803 · Mean difference (final values): -0.045 · 95% CI -0.405 to 0.315
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.159 · Mean difference (final values): -0.256 · 95% CI -0.615 to 0.103
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.110 · Mean difference (final values): -0.527 · 95% CI -1.176 to 0.122
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.003 · Mean difference (final values): -1.032 · 95% CI -1.691 to -0.373
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -1.065 · 95% CI -1.654 to -0.476
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -1.298 · 95% CI -1.869 to -0.728
SecondaryChange 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

Time frame:
Baseline, Week 12
Reported as:
Mean · mmHg
Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)
mmHgLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-4.90 (-9.049 to -0.746)-5.12 (-9.403 to -0.834)-6.36 (-9.781 to -2.935)-6.94 (-10.233 to -3.655)-5.36 (-8.758 to -1.961)
Dysglycemic-5.79 (-12.457 to 0.883)-7.10 (-13.825 to -0.369)-3.58 (-8.811 to 1.657)-4.17 (-9.399 to 1.051)-7.09 (-12.294 to -1.891)
T2DM-4.16 (-9.414 to 1.091)-2.96 (-8.500 to 2.588)-8.63 (-13.143 to -4.120)-9.00 (-13.182 to -4.810)-3.77 (-8.255 to 0.724)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.865 · Mean difference (final values): 0.46 · 95% CI -4.898 to 5.822
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.931 · Mean difference (final values): 0.24 · 95% CI -5.235 to 5.716
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.682 · Mean difference (final values): -1.00 · 95% CI -5.817 to 3.820
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.508 · Mean difference (final values): -1.58 · 95% CI -6.312 to 3.142
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.757 · Mean difference (final values): 1.31 · 95% CI -7.138 to 9.749
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.999 · Mean difference (final values): 0.00 · 95% CI -8.571 to 8.563
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.342 · Mean difference (final values): 3.52 · 95% CI -3.848 to 10.880
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.430 · Mean difference (final values): 2.92 · 95% CI -4.454 to 10.292
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.909 · Mean difference (final values): -0.40 · 95% CI -7.312 to 6.520
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.821 · Mean difference (final values): 0.81 · 95% CI -6.311 to 7.930
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.132 · Mean difference (final values): -4.87 · 95% CI -11.240 to 1.508
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.093 · Mean difference (final values): -5.23 · 95% CI -11.367 to 0.905
SecondaryChange 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

Time frame:
Baseline, Week 12
Reported as:
Mean · mmHg
Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)
mmHgLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-3.72 (-6.803 to -0.627)-3.54 (-6.700 to -0.377)-4.36 (-6.892 to -1.818)-5.23 (-7.677 to -2.788)-3.12 (-5.647 to -0.597)
Dysglycemic-3.32 (-8.404 to 1.769)-4.40 (-9.490 to 0.699)-2.46 (-6.441 to 1.513)-4.25 (-8.230 to -0.279)-4.31 (-8.257 to -0.357)
T2DM-4.00 (-7.943 to -0.059)-2.45 (-6.584 to 1.687)-5.98 (-9.352 to -2.607)-5.92 (-9.066 to -2.776)-1.93 (-5.303 to 1.448)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.769 · Mean difference (final values): -0.59 · 95% CI -4.579 to 3.393
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.839 · Mean difference (final values): -0.42 · 95% CI -4.462 to 3.630
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.496 · Mean difference (final values): -1.23 · 95% CI -4.811 to 2.345
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.237 · Mean difference (final values): -2.11 · 95% CI -5.622 to 1.402
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.758 · Mean difference (final values): 0.99 · 95% CI -5.435 to 7.415
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.978 · Mean difference (final values): -0.09 · 95% CI -6.574 to 6.397
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.512 · Mean difference (final values): 1.84 · 95% CI -3.758 to 7.444
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.985 · Mean difference (final values): 0.05 · 95% CI -5.552 to 5.657
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.428 · Mean difference (final values): -2.07 · 95% CI -7.268 to 3.121
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.846 · Mean difference (final values): -0.52 · 95% CI -5.853 to 4.812
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.095 · Mean difference (final values): -4.05 · 95% CI -8.825 to 0.721
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.089 · Mean difference (final values): -3.99 · 95% CI -8.610 to 0.623
SecondaryPercentage 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percentage
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)
PercentageLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study1.840 (-30.956 to 34.636)11.057 (-22.372 to 44.487)43.928 (17.118 to 70.737)5.307 (-20.648 to 31.261)17.401 (-9.474 to 44.275)
Dysglycemic-1.153 (-62.637 to 60.331)-1.986 (-64.104 to 60.132)52.284 (3.839 to 100.729)14.061 (-34.625 to 62.746)20.962 (-27.416 to 69.340)
T2DM1.016 (-36.069 to 38.100)23.108 (-14.937 to 61.153)34.747 (3.600 to 65.893)-0.057 (-29.478 to 29.363)13.806 (-17.085 to 44.697)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.470 · Mean difference (final values): -15.561 · 95% CI -58.106 to 26.985
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.770 · Mean difference (final values): -6.343 · 95% CI -49.187 to 36.501
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.169 · Mean difference (final values): 26.527 · 95% CI -11.462 to 64.516
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.521 · Mean difference (final values): -12.094 · 95% CI -49.345 to 25.157
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.571 · Mean difference (final values): -22.115 · 95% CI -100.058 to 55.828
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.564 · Mean difference (final values): -22.948 · 95% CI -102.325 to 56.429
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.359 · Mean difference (final values): 31.322 · 95% CI -36.712 to 99.356
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.842 · Mean difference (final values): -6.901 · 95% CI -76.093 to 62.290
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.601 · Mean difference (final values): -12.790 · 95% CI -61.417 to 35.836
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.705 · Mean difference (final values): 9.302 · 95% CI -39.517 to 58.121
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.346 · Mean difference (final values): 20.940 · 95% CI -23.126 to 65.007
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.516 · Mean difference (final values): -13.863 · 95% CI -56.283 to 28.556
SecondaryPercentage 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percentage
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol
PercentageLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-1.290 (-6.809 to 4.229)-2.983 (-8.711 to 2.745)0.884 (-3.663 to 5.430)0.302 (-4.096 to 4.700)-2.244 (-6.800 to 2.312)
Dysglycemic-3.055 (-12.284 to 6.173)-6.017 (-15.916 to 3.882)4.273 (-3.085 to 11.630)-1.734 (-9.000 to 5.532)-3.559 (-10.940 to 3.822)
T2DM0.158 (-6.814 to 7.129)-1.367 (-8.670 to 5.937)-1.646 (-7.772 to 4.481)1.817 (-3.857 to 7.491)-0.671 (-6.635 to 5.294)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.792 · Mean difference (final values): 0.955 · 95% CI -6.185 to 8.095
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.843 · Mean difference (final values): -0.739 · 95% CI -8.100 to 6.623
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.339 · Mean difference (final values): 3.128 · 95% CI -3.322 to 9.578
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.426 · Mean difference (final values): 2.546 · 95% CI -3.764 to 8.856
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.932 · Mean difference (final values): 0.504 · 95% CI -11.299 to 12.307
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.700 · Mean difference (final values): -2.458 · 95% CI -15.217 to 10.302
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.131 · Mean difference (final values): 7.832 · 95% CI -2.406 to 18.070
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.727 · Mean difference (final values): 1.825 · 95% CI -8.619 to 12.269
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.857 · Mean difference (final values): 0.828 · 95% CI -8.342 to 9.999
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.883 · Mean difference (final values): -0.696 · 95% CI -10.126 to 8.734
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.821 · Mean difference (final values): -0.975 · 95% CI -9.547 to 7.597
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.547 · Mean difference (final values): 2.488 · 95% CI -5.730 to 10.706
SecondaryPercentage 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percentage
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)
PercentageLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study1.499 (-3.683 to 6.682)-2.461 (-7.790 to 2.868)-5.253 (-9.514 to -0.993)0.112 (-4.014 to 4.237)-3.454 (-7.739 to 0.830)
Dysglycemic-0.519 (-9.144 to 8.107)0.329 (-8.368 to 9.027)-3.279 (-10.056 to 3.498)-0.147 (-6.917 to 6.622)-4.329 (-11.096 to 2.437)
T2DM2.886 (-3.774 to 9.545)-4.696 (-11.654 to 2.261)-6.993 (-12.672 to -1.315)0.235 (-5.133 to 5.604)-2.677 (-8.484 to 3.130)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.148 · Mean difference (final values): 4.954 · 95% CI -1.781 to 11.689
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.775 · Mean difference (final values): 0.993 · 95% CI -5.869 to 7.855
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.556 · Mean difference (final values): -1.799 · 95% CI -7.826 to 4.229
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.238 · Mean difference (final values): 3.566 · 95% CI -2.391 to 9.524
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.488 · Mean difference (final values): 3.811 · 95% CI -7.152 to 14.774
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.400 · Mean difference (final values): 4.659 · 95% CI -6.363 to 15.680
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.826 · Mean difference (final values): 1.050 · 95% CI -8.525 to 10.626
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.384 · Mean difference (final values): 4.182 · 95% CI -5.389 to 13.753
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.217 · Mean difference (final values): 5.563 · 95% CI -3.360 to 14.486
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.659 · Mean difference (final values): -2.019 · 95% CI -11.112 to 7.074
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.291 · Mean difference (final values): -4.316 · 95% CI -12.423 to 3.791
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.470 · Mean difference (final values): 2.913 · 95% CI -5.090 to 10.916
SecondaryPercentage 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percentage
Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)
PercentageLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study0.757 (-7.220 to 8.734)-2.363 (-10.702 to 5.975)0.037 (-6.524 to 6.598)4.726 (-1.616 to 11.068)-0.552 (-7.154 to 6.051)
Dysglycemic-3.065 (-16.507 to 10.376)-4.473 (-18.904 to 9.958)2.579 (-8.102 to 13.259)2.128 (-8.426 to 12.681)-3.994 (-14.722 to 6.735)
T2DM3.727 (-6.379 to 13.833)-1.562 (-12.127 to 9.004)-1.295 (-10.099 to 7.510)6.803 (-1.311 to 14.917)2.942 (-5.699 to 11.584)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.802 · Mean difference (final values): 1.308 · 95% CI -9.001 to 11.617
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.739 · Mean difference (final values): -1.812 · 95% CI -12.567 to 8.943
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.901 · Mean difference (final values): 0.588 · 95% CI -8.745 to 9.922
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.255 · Mean difference (final values): 5.278 · 95% CI -3.852 to 14.407
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.914 · Mean difference (final values): 0.928 · 95% CI -16.271 to 18.127
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.959 · Mean difference (final values): -0.480 · 95% CI -19.030 to 18.070
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.380 · Mean difference (final values): 6.572 · 95% CI -8.343 to 21.487
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.419 · Mean difference (final values): 6.121 · 95% CI -8.986 to 21.228
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.906 · Mean difference (final values): 0.785 · 95% CI -12.450 to 14.020
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.513 · Mean difference (final values): -4.504 · 95% CI -18.195 to 9.187
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.499 · Mean difference (final values): -4.237 · 95% CI -16.691 to 8.216
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.516 · Mean difference (final values): 3.860 · 95% CI -7.948 to 15.669
SecondaryPercent 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percentage
Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)
PercentageLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-48.448 (-193.256 to 96.359)69.004 (-75.849 to 213.858)-24.207 (-135.765 to 87.352)-55.536 (-163.215 to 52.144)-93.268 (-202.833 to 16.296)
Dysglycemic16.582 (-128.374 to 161.538)6.593 (-132.996 to 146.182)-36.745 (-140.259 to 66.770)-43.562 (-145.987 to 58.864)-6.298 (-108.747 to 96.151)
T2DM-89.337 (-336.322 to 157.648)113.169 (-128.460 to 354.798)-18.143 (-211.748 to 175.463)-71.025 (-252.712 to 110.662)-174.159 (-362.344 to 14.026)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.625 · Mean difference (final values): 44.820 · 95% CI -136.644 to 226.284
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.079 · Mean difference (final values): 162.273 · 95% CI -19.326 to 343.871
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.384 · Mean difference (final values): 69.062 · 95% CI -87.493 to 225.617
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.627 · Mean difference (final values): 37.733 · 95% CI -115.580 to 191.045
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.797 · Mean difference (final values): 22.879 · 95% CI -155.244 to 201.003
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.882 · Mean difference (final values): 12.891 · 95% CI -160.215 to 185.996
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.675 · Mean difference (final values): -30.447 · 95% CI -175.796 to 114.902
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.607 · Mean difference (final values): -37.264 · 95% CI -182.099 to 107.571
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.591 · Mean difference (final values): 84.822 · 95% CI -229.131 to 398.775
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.066 · Mean difference (final values): 287.328 · 95% CI -19.533 to 594.190
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.252 · Mean difference (final values): 156.017 · 95% CI -113.963 to 425.997
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.431 · Mean difference (final values): 103.135 · 95% CI -157.287 to 363.556
SecondaryChange 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

Time frame:
Baseline, Week 12
Reported as:
Mean · μmol/L
Change From Baseline in Uric Acid at Week 12
μmol/LLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-52.6 (-72.632 to -32.593)-55.2 (-75.682 to -34.817)-58.4 (-74.803 to -41.984)-62.0 (-77.864 to -46.067)12.4 (-3.832 to 28.722)
Dysglycemic-74.9 (-113.538 to -36.208)-74.0 (-111.662 to -36.430)-69.1 (-99.317 to -38.888)-72.9 (-103.215 to -42.510)12.0 (-17.580 to 41.628)
T2DM-34.1 (-54.663 to -13.537)-39.7 (-61.360 to -18.050)-48.4 (-65.970 to -30.840)-51.6 (-68.270 to -34.980)13.4 (-4.200 to 30.954)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -65.1 · 95% CI -90.864 to -39.251
  • LIK066 10mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -67.7 · 95% CI -93.848 to -41.542
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -70.8 · 95% CI -93.942 to -47.735
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -74.4 · 95% CI -97.117 to -51.704
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -86.9 · 95% CI -135.780 to -38.013
  • LIK066 10mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -86.1 · 95% CI -134.266 to -37.874
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -81.1 · 95% CI -123.369 to -38.883
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -84.9 · 95% CI -127.104 to -42.669
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -47.5 · 95% CI -74.493 to -20.461
  • LIK066 10mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -53.1 · 95% CI -80.914 to -25.251
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -61.8 · 95% CI -86.627 to -36.937
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): -65.0 · 95% CI -89.291 to -40.713
SecondaryChange 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

Time frame:
Baseline, Week 12
Reported as:
Mean · x 10^4 mmol/L
Change From Baseline on Urine Albumin at Week 12
x 10^4 mmol/LLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-1.838 (-4.665 to 0.990)0.008 (-2.891 to 2.907)-3.902 (-6.233 to -1.572)-3.099 (-5.360 to -0.838)-1.282 (-3.603 to 1.040)
Dysglycemic-1.941 (-3.792 to -0.089)2.030 (0.184 to 3.875)-2.456 (-3.934 to -0.978)-3.406 (-4.857 to -1.954)-3.611 (-5.062 to -2.161)
T2DM-3.899 (-7.776 to -0.022)-1.051 (-5.051 to 2.949)-3.605 (-6.864 to -0.345)-2.165 (-5.262 to 0.932)-0.174 (-3.442 to 3.094)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.764 · Mean difference (final values): -0.556 · 95% CI -4.210 to 3.098
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.493 · Mean difference (final values): 1.289 · 95% CI -2.423 to 5.001
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.117 · Mean difference (final values): -2.621 · 95% CI -5.908 to 0.666
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.269 · Mean difference (final values): -1.818 · 95% CI -5.056 to 1.421
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.159 · Mean difference (final values): 1.671 · 95% CI -0.676 to 4.017
  • LIK066 10mg qd vs Placebo · ANCOVA · p = <0.001 · Mean difference (final values): 5.641 · 95% CI 3.294 to 7.988
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.271 · Mean difference (final values): 1.155 · 95% CI -0.929 to 3.239
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.841 · Mean difference (final values): 0.206 · 95% CI -1.842 to 2.253
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.144 · Mean difference (final values): -3.725 · 95% CI -8.758 to 1.309
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.736 · Mean difference (final values): -0.877 · 95% CI -6.055 to 4.302
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.143 · Mean difference (final values): -3.431 · 95% CI -8.051 to 1.190
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.383 · Mean difference (final values): -1.991 · 95% CI -6.521 to 2.538
SecondaryChange 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

Time frame:
Baseline, Week 12
Reported as:
Mean · mg/mmol
Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12
mg/mmolLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-0.849 (-2.602 to 0.903)-0.848 (-2.648 to 0.951)-2.552 (-4.021 to -1.083)-1.878 (-3.283 to -0.473)-1.504 (-2.975 to -0.032)
Dysglycemic-0.553 (-1.449 to 0.343)0.487 (-0.411 to 1.384)-0.771 (-1.481 to -0.061)-1.018 (-1.718 to -0.319)-1.122 (-1.826 to -0.419)
T2DM-1.234 (-4.334 to 1.867)-1.863 (-5.117 to 1.391)-4.005 (-6.751 to -1.259)-2.631 (-5.146 to -0.116)-1.839 (-4.612 to 0.934)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.572 · Mean difference (final values): 0.654 · 95% CI -1.632 to 2.941
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.578 · Mean difference (final values): 0.655 · 95% CI -1.670 to 2.980
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.319 · Mean difference (final values): -1.048 · 95% CI -3.124 to 1.028
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.717 · Mean difference (final values): -0.374 · 95% CI -2.416 to 1.667
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.317 · Mean difference (final values): 0.570 · 95% CI -0.562 to 1.701
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.007 · Mean difference (final values): 1.609 · 95% CI 0.460 to 2.758
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.487 · Mean difference (final values): 0.352 · 95% CI -0.659 to 1.362
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.833 · Mean difference (final values): 0.104 · 95% CI -0.884 to 1.092
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.771 · Mean difference (final values): 0.605 · 95% CI -3.541 to 4.752
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.991 · Mean difference (final values): -0.024 · 95% CI -4.315 to 4.267
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.271 · Mean difference (final values): -2.166 · 95% CI -6.064 to 1.732
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.676 · Mean difference (final values): -0.792 · 95% CI -4.570 to 2.986
SecondaryPercent 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percent
Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12
PercentLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-4.139 (-11.464 to 3.185)-5.832 (-13.164 to 1.500)-9.185 (-15.209 to -3.161)-11.352 (-17.098 to -5.606)-3.949 (-9.865 to 1.967)
Dysglycemic-1.532 (-11.150 to 8.085)-6.438 (-15.501 to 2.625)-5.977 (-13.567 to 1.612)-7.333 (-14.876 to 0.209)-0.390 (-7.673 to 6.893)
T2DM-6.461 (-17.485 to 4.563)-5.934 (-17.568 to 5.699)-12.916 (-22.387 to -3.445)-14.728 (-23.368 to -6.087)-7.137 (-16.553 to 2.280)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.968 · Mean difference (final values): -0.190 · 95% CI -9.603 to 9.222
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.693 · Mean difference (final values): -1.883 · 95% CI -11.297 to 7.531
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.222 · Mean difference (final values): -5.236 · 95% CI -13.676 to 3.203
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.078 · Mean difference (final values): -7.403 · 95% CI -15.648 to 0.841
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.850 · Mean difference (final values): -1.142 · 95% CI -13.194 to 10.910
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.301 · Mean difference (final values): -6.048 · 95% CI -17.676 to 5.580
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.293 · Mean difference (final values): -5.587 · 95% CI -16.147 to 4.972
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.189 · Mean difference (final values): -6.943 · 95% CI -17.421 to 3.535
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.926 · Mean difference (final values): 0.676 · 95% CI -13.800 to 15.152
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.873 · Mean difference (final values): 1.202 · 95% CI -13.802 to 16.207
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.391 · Mean difference (final values): -5.779 · 95% CI -19.164 to 7.605
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.239 · Mean difference (final values): -7.591 · 95% CI -20.345 to 5.163
SecondaryPercent 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

Time frame:
Baseline, Week 12
Reported as:
Mean · Percentage
Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12
PercentageLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlacebo
Overall Study-6.562 (-10.835 to -2.290)-4.454 (-8.812 to -0.095)-7.983 (-11.479 to -4.488)-5.745 (-9.068 to -2.422)-3.477 (-7.051 to 0.097)
Dysglycemic-7.745 (-14.320 to -1.169)-5.962 (-12.310 to 0.386)-7.234 (-12.449 to -2.018)-2.127 (-7.286 to 3.031)-4.328 (-9.502 to 0.845)
T2DM-5.457 (-11.198 to 0.284)-3.646 (-9.864 to 2.571)-8.415 (-13.227 to -3.602)-8.481 (-12.874 to -4.087)-2.821 (-7.865 to 2.223)
Statistical analysis
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.278 · Mean difference (final values): -3.086 · 95% CI -8.696 to 2.525
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.733 · Mean difference (final values): -0.977 · 95% CI -6.639 to 4.686
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.075 · Mean difference (final values): -4.507 · 95% CI -9.482 to 0.468
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.360 · Mean difference (final values): -2.268 · 95% CI -7.152 to 2.616
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.416 · Mean difference (final values): -3.147 · 95% CI -11.792 to 4.959
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.693 · Mean difference (final values): -1.634 · 95% CI -9.893 to 6.625
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.428 · Mean difference (final values): -2.906 · 95% CI -10.207 to 4.396
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.548 · Mean difference (final values): 2.201 · 95% CI -5.113 to 9.515
  • LIK066 2.5mg qd vs Placebo · ANCOVA · p = 0.500 · Mean difference (final values): -2.636 · 95% CI -10.400 to 5.128
  • LIK066 10mg qd vs Placebo · ANCOVA · p = 0.837 · Mean difference (final values): -0.826 · 95% CI -8.805 to 7.154
  • LIK066 25 mg qd vs Placebo · ANCOVA · p = 0.113 · Mean difference (final values): -5.594 · 95% CI -12.556 to 1.368
  • LIK066 50 mg qd vs Placebo · ANCOVA · p = 0.096 · Mean difference (final values): -5.660 · 95% CI -12.361 to 1.041
SecondaryPharmacokinetics - 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).

Time frame:
Week 12
Reported as:
Mean · ng/mL
Pharmacokinetics - Plasma Trough Concentrations of LIK066
ng/mLLIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qd
Pharmacokinetics - Plasma Trough Concentrations of LIK0661.63 ± 0.9474.17 ± 2.9412.8 ± 8.5626.4 ± 21.8

Adverse events

Collected over 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). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LIK066 2.5mg qd0/19 (0%)0/19 (0%)10/19 (52.6%)
LIK066 10mg qd0/19 (0%)0/19 (0%)12/19 (63.2%)
LIK066 25mg qd0/28 (0%)0/28 (0%)13/28 (46.4%)
LIK066 50mg qd0/31 (0%)1/31 (3.2%)20/31 (64.5%)
Placebo0/29 (0%)0/29 (0%)9/29 (31%)
Most frequent serious events
Most frequent serious events
EventLIK066 2.5mg qdLIK066 10mg qdLIK066 25mg qdLIK066 50mg qdPlacebo
Cholecystitis acuteHepatobiliary disorders0/190/190/281/310/29
Most frequent other events
Showing 10 of 32
Most frequent other events
EventLIK066 2.5mg qdLIK066 10mg qdLIK066 25mg qdLIK066 50mg qdPlacebo
DiarrhoeaGastrointestinal disorders0/190/194/2812/312/29
NasopharyngitisInfections and infestations2/193/195/284/311/29
Urine albumin/creatinine ratio increasedInvestigations0/192/190/282/312/29
Gastrooesophageal reflux diseaseGastrointestinal disorders1/190/192/280/311/29
Protein urine presentInvestigations1/190/192/280/311/29
HypoglycaemiaMetabolism and nutrition disorders0/191/192/282/312/29
HeadacheNervous system disorders0/190/190/280/312/29
FlatulenceGastrointestinal disorders0/190/190/282/310/29
VertigoEar and labyrinth disorders0/191/190/280/310/29
Gastric polypsGastrointestinal disorders0/191/191/280/310/29

Baseline characteristics

Age, Continuous
Age, Continuous(years)LIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlaceboTotal
Mean57.2 ± 10.4457.2 ± 7.5456.8 ± 9.5057.9 ± 11.3759.3 ± 9.7657.7 ± 9.83
Sex: Female, Male
Sex: Female, Male(Participants)LIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlaceboTotal
Female4711141248
Male151217171778
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LIK066 2.5mg qdLIK066 10mg qdLIK066 25 mg qdLIK066 50 mg qdPlaceboTotal
American Indian or Alaska Native000000
Asian1919283129126
Native Hawaiian or Other Pacific Islander000000
Black or African American000000
White000000
More than one race000000
Unknown or Not Reported000000
08

Study locations

24 sites
  • Novartis Investigative Site
    Matsudo city, Chiba 271 0077, Japan
  • Novartis Investigative Site
    Chikushino-city, Fukuoka 818-0036, Japan
  • Novartis Investigative Site
    Fukuoka-city, Fukuoka 810-0066, Japan
  • Novartis Investigative Site
    Fukuoka-city, Fukuoka 819-0006, Japan
  • Novartis Investigative Site
    Kitakyushu-city, Fukuoka 807-0857, Japan
  • Novartis Investigative Site
    Akashi, Hyogo 674-0081, Japan
  • Novartis Investigative Site
    Kakogawa-city, Hyogo 675-0101, Japan
  • Novartis Investigative Site
    Yokohama-city, Kanagawa 231-0023, Japan
  • Novartis Investigative Site
    Kumamoto City, Kumamoto 860-0863, Japan
  • Novartis Investigative Site
    Kumamoto-city, Kumamoto 860-8039, Japan
  • Novartis Investigative Site
    Kyoto city, Kyoto 600-8898, Japan
  • Novartis Investigative Site
    Kyoto-city, Kyoto 615-8125, Japan
  • Novartis Investigative Site
    Nagasaki city, Nagasaki 850 0045, Japan
  • Novartis Investigative Site
    Higashiosaka-city, Osaka 577-0802, Japan
  • Novartis Investigative Site
    Higashiosaka-city, Osaka 577-0803, Japan
  • Novartis Investigative Site
    Ageo-city, Saitama 362-8588, Japan
  • Novartis Investigative Site
    Kawaguchi-City, Saitama 332 0021, Japan
  • Novartis Investigative Site
    Tokorozawa-city, Saitama 359-0042, Japan
  • Novartis Investigative Site
    Tokorozawa, Saitama, Japan
  • Novartis Investigative Site
    Hachioji-city, Tokyo 192-0046, Japan
  • Novartis Investigative Site
    Kiyose-city, Tokyo 204-0021, Japan
  • Novartis Investigative Site
    Minato-ku, Tokyo 108-0075, Japan
  • Novartis Investigative Site
    Shinagawa-ku, Tokyo 141-0032, Japan
  • Novartis Investigative Site
    Toshima-ku, Tokyo 171-0021, Japan
09

References and documents

Publications

  • 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. PubMed 32072763 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Jul 2018, 7 months.

Results were first posted in Oct 2019, 1 year 2 months after primary completion.

Of 176 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's 7 months is below that.

Counting every sponsor, half of 308 studies reached it within 16 months; a quarter within 10 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2017
First posted
Oct 25, 2017
StartActual
Dec 7, 2017
Primary completionActual
Jul 25, 2018
CompletionActual
Jul 25, 2018
Results first posted
Oct 2, 2019
Last update
Jun 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03320941
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
Dec 7, 2017
Primary completion
Jul 25, 2018
Completion
Jul 25, 2018
Results posted
Oct 2, 2019
Last update
Jun 26, 2024

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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