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

Novartis Pharmaceuticals52 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Interventions

LCQ908DRUG

LCQ908 5 mg, 10 mg, 20 mg tablets

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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: 1. Stable dose of anti-diabetic medications (metformin and/or sulfonylureas) for at least 8 weeks prior to screening. 2. Stable doses of beta-blockers and thiazide diuretics for at least 8 weeks prior to screening. 3. Stable doses of fibrates, statins, niacin, ezetimibe for at least 8 weeks prior to screening. 4. 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

Locations (11)

Novartis Investigative Site

Mobile, Alabama, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at 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).

Time frame: From baseline to week 24

Secondary Outcomes

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

Time frame: From baseline to week 12

Percentage of Responders 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.

Time frame: At week 12

Percentage of Responders at Week 24

Time frame: From baseline to week 24

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.