Trial · NCT03205150

Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients

NCT03205150, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-01-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients. Trials, record NCT03205150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03205150

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Trial

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

Title: Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients
NCT number: NCT03205150
Status: Completed
Phases: Phase 2
Enrollment: 107 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Obese Patients With Non-alcoholic Steatohepatitis (NASH)
Interventions: LIK066, Placebo
First posted: 2017-07-02
Last updated: 2021-10-08
Other registries' IDs: eudract:2017-002046-71
Results first posted: 2021-01-06

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Alanine Aminotransferase (ALT) at Week 12	Baseline, Week 12	Alanine aminotransferase (ALT) is an enzyme found primarily in the liver. ALT is increased with liver damage. In this study, the blood levels of ALT was used to detect liver injury. Baseline is defined as the mean of measurements taken at the Screening and Baseline visits.
Secondary	Change From Baseline in Percent Liver Fat at Week 12	Baseline, Week 12	Percent (%) Liver fat was measured by Magnetic Resonance Imaging Proton Density Liver Fat Fraction(MRIPDFF). Patients underwent magnetic resonance imaging twice during the course of the study ( baseline and end of treatment) to quantitate liver fat.
Secondary	Percent Change From Baseline in Total Body Weight at Week 12	Baseline, Week 12	Body weight (to the nearest 0.1 kilogram \[kg\] was measured on a calibrated scale. The measurement was performed with the study subject in underwear and without shoes; or while wearing minimal indoor clothing.
Secondary	Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Week 12	Baseline, Week 12	The markers of fibrosis assessed in this test comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during fibrogenesis as a result of activation of the hepatic stellate cell. The ELF test is a composite score: \< 7.7: no to mild fibrosis; ≥ 7.7 - \< 9.8: Moderate fibrosis; ≥ 9.8 - \< 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis.
Secondary	Change From Baseline in the Concentration of Hyaluronic Acid at Week 12.	Baseline, Week 12	Hyaluronic Acid is a non-invasive marker of liver fibrosis. It was accessed by Enhanced liver fibrosis Test (ELF).
Secondary	Change From Baseline in the Concentration of Procollagen Type Iii N-Terminal Peptide (PIIINP) at Week 12.	Baseline, Week 12	PIIINP is a non-invasive marker of liver fibrosis. It was accessed by Enhanced liver fibrosis Test (ELF).
Secondary	Change From Baseline in the Concentration of Tissue Inhibitor Of Metalloproteinase 1 (TIMP-1) at Week 12.	Baseline, Week 12	TIMP-1 is a non-invasive marker of liver fibrosis. It was accessed by Enhanced liver fibrosis Test (ELF).
Secondary	Pharmacokinetics of LIK066: Observed Maximum Plasma Concentration (Cmax) Following Drug Administration	Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)	Cmax is the observed maximum plasma concentration following drug administration (ng/mL)
Secondary	Pharmacokinetics of LIK066: Observed Maximum Time Duration of Maximum Concentration (Tmax) Following Drug Administration	Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)	Tmax is the time to reach the maximum concentration after drug administration (hour). The time points presented are the actual and not the planned time points.
Secondary	Pharmacokinetics of LIK066: Observed Area Under the Curve up to the Last Measurable Concentration (AUClast) Following Drug Administration	Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)	AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (hour\*ng/mL)

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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 Alanine Aminotransferase (ALT) at Week 12	Baseline, Week 12	Pharmacodynamics (PD) analysis set: included all participants with available PD data, who received any study drug and had valid measurements for the outcome measure	Units per Liter (U/L)	MEAN
SECONDARY	Change From Baseline in Percent Liver Fat at Week 12	Baseline, Week 12	Pharmacodynamics (PD) analysis set: included all participants with available PD data, who received any study drug and had valid measurements for the outcome measure	Percentage of Liver Fat	MEAN
SECONDARY	Percent Change From Baseline in Total Body Weight at Week 12	Baseline, Week 12	Pharmacodynamics (PD) analysis set: included all participants with available PD data, who received any study drug and had valid measurements for the outcome measure	percentage change	MEAN
SECONDARY	Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Week 12	Baseline, Week 12	Pharmacodynamics (PD) analysis set: included all participants with available PD data, who received any study drug and had valid measurements for the outcome measure	scores on a scale	MEAN
SECONDARY	Change From Baseline in the Concentration of Hyaluronic Acid at Week 12.	Baseline, Week 12	Pharmacodynamics (PD) analysis set: included all participants with available PD data, who received any study drug and had valid measurements for the outcome measure	ug/L	MEAN
SECONDARY	Change From Baseline in the Concentration of Procollagen Type Iii N-Terminal Peptide (PIIINP) at Week 12.	Baseline, Week 12	Pharmacodynamics (PD) analysis set: included all participants with available PD data, who received any study drug and had valid measurements for the outcome measure	ug/L	MEAN
SECONDARY	Change From Baseline in the Concentration of Tissue Inhibitor Of Metalloproteinase 1 (TIMP-1) at Week 12.	Baseline, Week 12	Pharmacodynamics (PD) analysis set: included all participants with available PD data, who received any study drug and had valid measurements for the outcome measure	ug/L	MEAN
SECONDARY	Pharmacokinetics of LIK066: Observed Maximum Plasma Concentration (Cmax) Following Drug Administration	Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)	Pharmacokinetics (PK) analysis set consisted of LIK066 treated patients. Placebo patients were excluded from the PK analysis	ng/mL	MEAN
SECONDARY	Pharmacokinetics of LIK066: Observed Maximum Time Duration of Maximum Concentration (Tmax) Following Drug Administration	Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)	Pharmacokinetics (PK) analysis set consisted of LIK066 treated patients. Placebo patients were excluded from the PK analysis	hours	MEDIAN
SECONDARY	Pharmacokinetics of LIK066: Observed Area Under the Curve up to the Last Measurable Concentration (AUClast) Following Drug Administration	Day 56 (pre-dose and 1, 2, 4 and 6 hours post-dose)	Pharmacokinetics (PK) analysis set consisted of LIK066 treated patients. Placebo patients were excluded from the PK analysis	hour*ng/mL	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group30

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12	LIK066 30 mg	-22.06	Standard Error 4.16	Units per Liter (U/L)
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12	LIK066 150 mg	-30.41	Standard Error 4.52	Units per Liter (U/L)
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12	Placebo	-8.77	Standard Error 5.99	Units per Liter (U/L)
Change From Baseline in Percent Liver Fat at Week 12	LIK066 30 mg	-4.40	Standard Error 0.81	Percentage of Liver Fat
Change From Baseline in Percent Liver Fat at Week 12	LIK066 150 mg	-6.92	Standard Error 0.87	Percentage of Liver Fat
Change From Baseline in Percent Liver Fat at Week 12	Placebo	-2.67	Standard Error 1.17	Percentage of Liver Fat
Percent Change From Baseline in Total Body Weight at Week 12	LIK066 30 mg	-3.48	Standard Error 0.47	percentage change
Percent Change From Baseline in Total Body Weight at Week 12	LIK066 150 mg	-4.51	Standard Error 0.52	percentage change
Percent Change From Baseline in Total Body Weight at Week 12	Placebo	-0.33	Standard Error 0.68	percentage change
Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Week 12	LIK066 30 mg	-0.2	Standard Deviation 0.65	scores on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	LIK066 30 mg	43
Overall Study	STARTED	LIK066 150 mg	43
Overall Study	STARTED	Placebo	21
Overall Study	Safety Analysis Set	LIK066 30 mg	43
Overall Study	Safety Analysis Set	LIK066 150 mg	43
Overall Study	Safety Analysis Set	Placebo	21
Overall Study	Pharmacokinetics (PK) Analysis Set	LIK066 30 mg	42
Overall Study	Pharmacokinetics (PK) Analysis Set	LIK066 150 mg	36
Overall Study	Pharmacokinetics (PK) Analysis Set	Placebo	0
Overall Study	Pharmacodynamics (PD) Analysis Set	LIK066 30 mg	43

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events440

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	Neutropenia	Blood and lymphatic system disorders	LIK066 30 mg	1	43
other	Neutropenia	Blood and lymphatic system disorders	LIK066 150 mg	0	43
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	21
other	Neutropenia	Blood and lymphatic system disorders	All Patients	1	107
other	Palpitations	Cardiac disorders	LIK066 30 mg	0	43
other	Palpitations	Cardiac disorders	LIK066 150 mg	1	43
other	Palpitations	Cardiac disorders	Placebo	1	21
other	Palpitations	Cardiac disorders	All Patients	2	107
other	Vertigo	Ear and labyrinth disorders	LIK066 30 mg	1	43
other	Vertigo	Ear and labyrinth disorders	LIK066 150 mg	0	43

1 to 10 of 440Source ClinicalTrials.gov

See all 440 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LIK066 30 mg	0	43
Total, all-cause mortality	LIK066 150 mg	0	43
Total, all-cause mortality	Placebo	0	21
Total, all-cause mortality	All Patients	0	107
Total, other adverse events	LIK066 30 mg	31	43
Total, other adverse events	LIK066 150 mg	36	43
Total, other adverse events	Placebo	18	21
Total, other adverse events	All Patients	85	107
Total, serious adverse events	LIK066 30 mg	0	43
Total, serious adverse events	LIK066 150 mg	0	43

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35725922	DERIVED

Source PubMed

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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