Trial · NCT03131479

Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

NCT03131479, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-02-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function. Trials, record NCT03131479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03131479

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.
NCT number: NCT03131479
Status: Completed
Phases: Phase 2
Enrollment: 53 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Renal Impairment
Interventions: LIK066
First posted: 2017-04-27
Last updated: 2021-01-05
Other registries' IDs: eudract:2016-004770-18
Results first posted: 2019-02-06

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7	Baseline , Day 7	Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function.
Primary	Maximum Observed Plasma Concentration (Cmax) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Primary	Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7	Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done.
Primary	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1	Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done.
Primary	Terminal Elimination Half-life (T1/2) for LIK066 on Day 7	Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to \~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done.
Primary	Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1	Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done.
Primary	Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1	Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.
Primary	Renal Clearance From Plasma (CLr) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations. CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7	Baseline , Day 7	Pharmacodynamic Analysis Set (PD), which consisted of all participants with an observed PD value, was considered. Only patients with evaluable data at each time point were analyzed for that time point.	gram (g)	MEAN
PRIMARY	Maximum Observed Plasma Concentration (Cmax) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.	nanogram per milliliter (ng/mL)	MEAN
PRIMARY	Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.	hour (hr)	MEDIAN
PRIMARY	Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.	hournanogram per milliliter (hrng/mL)	MEAN
PRIMARY	Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7	Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.	hournanogram per milliliter (hrng/mL)	MEAN
PRIMARY	Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1	Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.	hournanogram per milliliter (hrng/mL)	MEAN
PRIMARY	Terminal Elimination Half-life (T1/2) for LIK066 on Day 7	Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.	hour (hr)	MEAN
PRIMARY	Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1	Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.	Liter per hour (L/h)	MEAN
PRIMARY	Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1	Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.	Liter (L)	MEAN
PRIMARY	Renal Clearance From Plasma (CLr) for LIK066	Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)	Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.	Liter per hour (L/hr)	MEAN

Source ClinicalTrials.gov

Results by group70

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7	Normal		40.45	Standard Deviation 21.93	gram (g)
Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7	Mild		31.87	Standard Deviation 13.79	gram (g)
Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7	Moderate A		36.27	Standard Deviation 19.51	gram (g)
Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7	Moderate B		19.88	Standard Deviation 18.66	gram (g)
Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7	Severe		5.50	Standard Deviation 3.75	gram (g)
Maximum Observed Plasma Concentration (Cmax) for LIK066	Normal	Day 1	565	Standard Deviation 176	nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) for LIK066	Mild	Day 1	590	Standard Deviation 176	nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) for LIK066	Moderate A	Day 1	492	Standard Deviation 142	nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) for LIK066	Moderate B	Day 1	569	Standard Deviation 147	nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) for LIK066	Severe	Day 1	650	Standard Deviation 199	nanogram per milliliter (ng/mL)

1 to 10 of 70Source ClinicalTrials.gov

See all 70 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mild	10
Overall Study	STARTED	Moderate A	10
Overall Study	STARTED	Moderate B	11
Overall Study	STARTED	Severe	12
Overall Study	STARTED	Normal	10
Overall Study	Safety Analysis Set (SS)	Mild	10
Overall Study	Safety Analysis Set (SS)	Moderate A	10
Overall Study	Safety Analysis Set (SS)	Moderate B	11
Overall Study	Safety Analysis Set (SS)	Severe	12
Overall Study	Safety Analysis Set (SS)	Normal	10

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events75

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
other	Abdominal pain	Gastrointestinal disorders	Normal	2	10
other	Abdominal pain	Gastrointestinal disorders	Mild	2	10
other	Abdominal pain	Gastrointestinal disorders	Moderate A	1	10
other	Abdominal pain	Gastrointestinal disorders	Moderate B	3	11
other	Abdominal pain	Gastrointestinal disorders	Severe	3	12
other	Diarrhoea	Gastrointestinal disorders	Normal	9	10
other	Diarrhoea	Gastrointestinal disorders	Mild	10	10
other	Diarrhoea	Gastrointestinal disorders	Moderate A	10	10
other	Diarrhoea	Gastrointestinal disorders	Moderate B	10	11
other	Diarrhoea	Gastrointestinal disorders	Severe	11	12

1 to 10 of 75Source ClinicalTrials.gov

See all 75 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Normal	0	10
Total, all-cause mortality	Mild	0	10
Total, all-cause mortality	Moderate A	0	10
Total, all-cause mortality	Moderate B	0	11
Total, all-cause mortality	Severe	0	12
Total, other adverse events	Normal	9	10
Total, other adverse events	Mild	10	10
Total, other adverse events	Moderate A	10	10
Total, other adverse events	Moderate B	11	11
Total, other adverse events	Severe	11	12

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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