Trial · NCT02470403
Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index
NCT02470403, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2017-05-12
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ConductScience Library. Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index. Trials, record NCT02470403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02470403
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index
- NCT number
- NCT02470403
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 181 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Elevated Body Mass Index
- Interventions
- LIK066, Placebo
- First posted
- 2015-06-12
- Last updated
- 2021-01-05
- Results first posted
- 2017-05-12
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Percent Change in Body Weight From Baseline to Week 12 | Baseline, Week 12 (Day 85) | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as \[(post baseline- Baseline) /Baseline\] \* 100. A longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate. |
| Primary | Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 12 weeks | This endpoint reports patients with at least one AE (any AE), serious AE and death. |
| Primary | Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) | Baseline, Week 2 (Day 14) | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose. Percent change is calculated as \[(post baseline- Baseline) /Baseline\] \* 100. A longitudinal mixed effects model for percent change in body weight was used. The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate. |
| Primary | Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 2 weeks | This endpoint reports patients with at least one AE (any AE), serious AE and death |
| Secondary | Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms | Baseline, Week 2 | Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose. Percent change is calculated as \[(post baseline- Baseline) /Baseline\] \* 100. A longitudinal mixed effects model for percent change in body weight was used. The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate. |
| Secondary | Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study | Day 84 | Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. |
| Secondary | Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study | Day 84 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. |
| Secondary | Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study | Day 84 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. |
| Secondary | Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study | Day 84 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. |
| Secondary | The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study | Day 84 | Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Percent Change in Body Weight From Baseline to Week 12 | Baseline, Week 12 (Day 85) | The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement. | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 12 weeks | The safety analysis set included all subjects that received any study drug. | Patients | NUMBER |
| PRIMARY | Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) | Baseline, Week 2 (Day 14) | Pharmacodynamic set. The analysis was based on all subjects with a baseline body weight and at least one post-Baseline body weight measurement. Only data from common time points in Part 1 and Part 2 were included in the analysis, i.e., Baseline and Day 14. | Percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | 2 weeks | The safety analysis set included all subjects that received any study drug. | Patients | NUMBER |
| SECONDARY | Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms | Baseline, Week 2 | The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study | Day 84 | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study | Day 84 | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | hour | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study | Day 84 | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | hr*ng/mL | MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study | Day 84 | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | hr*ng/mL | MEAN |
| SECONDARY | The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study | Day 84 | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Liter/hour | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group119
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Percent Change in Body Weight From Baseline to Week 12 | Part 1: LIK066 150 mg Once Daily (qd) | All subjects (n= 42, 43) | -5.51 | 80% Confidence Interval -6.09 to -4.93 | percent change |
| Part 1: Percent Change in Body Weight From Baseline to Week 12 | Part 1: Placebo Once Daily | All subjects (n= 42, 43) | 0.19 | 80% Confidence Interval -0.39 to 0.78 | percent change |
| Part 1: Percent Change in Body Weight From Baseline to Week 12 | Part 1: LIK066 150 mg Once Daily (qd) | Dysglycemic subjects (n= 22, 23) | -6.55 | 80% Confidence Interval -7.34 to -5.77 | percent change |
| Part 1: Percent Change in Body Weight From Baseline to Week 12 | Part 1: Placebo Once Daily | Dysglycemic subjects (n= 22, 23) | 0.29 | 80% Confidence Interval -0.50 to 1.09 | percent change |
| Part 1: Percent Change in Body Weight From Baseline to Week 12 | Part 1: LIK066 150 mg Once Daily (qd) | Normoglycemic subjects (n= 20,20) | -4.46 | 80% Confidence Interval -5.31 to -3.60 | percent change |
| Part 1: Percent Change in Body Weight From Baseline to Week 12 | Part 1: Placebo Once Daily | Normoglycemic subjects (n= 20,20) | 0.09 | 80% Confidence Interval -0.77 to 0.94 | percent change |
| Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Part 1: LIK066 150 mg Once Daily (qd) | With at least one AE (any AE) | 43 | Patients | |
| Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Part 1: Placebo Once Daily | With at least one AE (any AE) | 39 | Patients | |
| Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Part 1: LIK066 150 mg Once Daily (qd) | Serious AE | 1 | Patients | |
| Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death | Part 1: Placebo Once Daily | Serious AE | 0 | Patients |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: LIK066 150 mg Once Daily (qd) | 44 | |
| Overall Study | STARTED | Part 1: Placebo Once Daily | 44 | |
| Overall Study | STARTED | Part 2: LIK066 75 mg Twice Daily (Bid) | 40 | |
| Overall Study | STARTED | Part 2: LIK066 50 mg Three Times Daily (Tid) | 43 | |
| Overall Study | STARTED | Part 2: Placebo Three Times Daily | 10 | |
| Overall Study | Dysglycemic | Part 1: LIK066 150 mg Once Daily (qd) | 24 | |
| Overall Study | Dysglycemic | Part 1: Placebo Once Daily | 24 | |
| Overall Study | Dysglycemic | Part 2: LIK066 75 mg Twice Daily (Bid) | 20 | |
| Overall Study | Dysglycemic | Part 2: LIK066 50 mg Three Times Daily (Tid) | 20 | |
| Overall Study | Dysglycemic | Part 2: Placebo Three Times Daily | 5 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events535
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | Part 1: LIK066 150 mg Once Daily (qd) | 0 | 44 | |
| other | Ear pain | Ear and labyrinth disorders | Part 1: Placebo Once Daily | 1 | 44 | |
| other | Ear pain | Ear and labyrinth disorders | Part 2: LIK066 75 mg Twice Daily (Bid) | 1 | 40 | |
| other | Ear pain | Ear and labyrinth disorders | Part 2: LIK066 50 mg Three Times Daily (Tid) | 0 | 43 | |
| other | Ear pain | Ear and labyrinth disorders | Part 2: Placebo Three Times Daily | 0 | 10 | |
| other | Visual impairment | Eye disorders | Part 1: LIK066 150 mg Once Daily (qd) | 1 | 44 | |
| other | Visual impairment | Eye disorders | Part 1: Placebo Once Daily | 0 | 44 | |
| other | Visual impairment | Eye disorders | Part 2: LIK066 75 mg Twice Daily (Bid) | 0 | 40 | |
| other | Visual impairment | Eye disorders | Part 2: LIK066 50 mg Three Times Daily (Tid) | 0 | 43 | |
| other | Visual impairment | Eye disorders | Part 2: Placebo Three Times Daily | 0 | 10 |
1 to 10 of 535Source ClinicalTrials.gov
See all 535 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: LIK066 150 mg Once Daily (qd) | ||
| Total, all-cause mortality | Part 1: Placebo Once Daily | ||
| Total, all-cause mortality | Part 2: LIK066 75 mg Twice Daily (Bid) | ||
| Total, all-cause mortality | Part 2: LIK066 50 mg Three Times Daily (Tid) | ||
| Total, all-cause mortality | Part 2: Placebo Three Times Daily | ||
| Total, other adverse events | Part 1: LIK066 150 mg Once Daily (qd) | 43 | 44 |
| Total, other adverse events | Part 1: Placebo Once Daily | 39 | 44 |
| Total, other adverse events | Part 2: LIK066 75 mg Twice Daily (Bid) | 40 | 40 |
| Total, other adverse events | Part 2: LIK066 50 mg Three Times Daily (Tid) | 43 | 43 |
| Total, other adverse events | Part 2: Placebo Three Times Daily | 10 | 10 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02470403
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