Skip to main content
OpenTrials
Completed

NCT Number: NCT01811472

Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients

The purpose of this study was to determine whether LCQ908 effectively lowers liver fat, as assessed by MRI and to assess its safety and tolerability profile in subjects with non-alcoholic fatty liver disease (NAFLD).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease (NAFLD) Digestive System Diseases Dyslipidemias Fatty Liver Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of liver steatosis during the preceding 24 months
  • History of fasting TGs > 200 mg/dL (confirmed at screening).
  • Liver fat ≥ 10% as determined by the central MRI laboratory.
  • Subjects on the following medications can be included if these medications are medically necessary, cannot be stopped and the investigator feels their dose will remain stable for the duration of the double-blind treatment period:
  • Stable dose of anti-diabetic medications (metformin and/or sulfonylureas) for at least 8 weeks prior to screening.
  • Stable doses of beta-blockers and thiazide diuretics for at least 8 weeks prior to screening.
  • Stable doses of fibrates, statins, niacin, ezetimibe for at least 8 weeks prior to screening.
  • Stable dose of vitamin E in patients taking >200 IU/day for at least 6 months prior to screening.

Exclusion criteria

  • Treatment with omega-3-acid ethyl esters or omega-3-polyunsaturated fatty acid (PUFA)-containing supplements > 200 mg per day within 8 weeks of screening.
  • Treatment with antiretrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within 8 weeks of screening.
  • ALT or AST > 250 IU/L at the time of screening.
  • History/current evidence of heavy alcohol use or alcoholism (> 21 drinks per week in men and > 14 drinks per week in women) over a 2-year period prior to screening.
  • Presence of chronic liver disease, such as chronic hepatitis B and/or C, alcoholic liver disease, hemochromatosis, Wilson's disease, known cirrhosis.
  • Platelet count <150,000 at screening.
  • BMI >45 Kg/m2.

Other protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

LCQ908

Drug

LCQ908 5 mg, 10 mg, 20 mg tablets

Other names: pradigastat

Placebo

Drug

Matching placebo of LCQ908 5 mg, 10 mg, 20 mg tablets.

Primary outcomes

  1. Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24

    Time frame: From baseline to week 24

    Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).

Secondary outcomes

  1. Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12

    Time frame: From baseline to week 12

    Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).

  2. Percentage of Responders at Week 12

    Time frame: At week 12

    The response criteria are defined as:

    a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit.

  3. Percentage of Responders at Week 24

    Time frame: From baseline to week 24

    The response criteria are defined as:

    a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit.

  4. Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6

    Time frame: From Baseline to week 6

    Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).

    Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.

  5. Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12

    Time frame: From Baseline to week 12

    Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).

    Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.

  6. Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24

    Time frame: From Baseline to week 24

    Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).

    Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate.

  7. Percentage of Patients With Normalized Liver Enzymes

    Time frame: Baseline, week 6, week 12 and week 24

    Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose.

  8. Percent Change From Baseline in Fasting Triglycerides

    Time frame: Baseline, 6, 12 and 24 weeks

    Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast.

    Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization).

  9. Post-prandial Peak Triglycerides Over 0 - 8 Hours

    Time frame: Baseline, 6 and 24 weeks

    Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours.

    Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization).

  10. Change From Baseline in Body Weight

    Time frame: Baseline, 12 and 24 weeks

  11. Change From Baseline in Waist Circumference

    Time frame: Baseline, 12 and 24 weeks

  12. Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group, 24-week Pilot Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in Patients With Non-alcoholic Fatty Liver Disease

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2013
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.