Trial · NCT02470403
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 |
| SECONDARY | The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, 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. | Liter | MEAN |
| SECONDARY | Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study | Day 1, Day 14 | 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 (Tmax) in Part 2 of the Study | Day 1, Day 14 | 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 (AUClast) of LIK066 in Part 2 of the Study | Day 1, Day 14 | 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 (AUCtau) of LIK066 in Part 2 of the Study | Day 1, Day 14 | 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) of LIK066 Following Extra Vascular Administration in Part 2 of the Study | Day 1, Day 14 | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Liter/hour | MEAN |
| SECONDARY | The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study | Day 1, Day 14 | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Liter | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02470403/outcomes