Phase 2
N=52
Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients
Non-alcoholic Fatty Liver Disease (NAFLD)
Bottom Line
View on ClinicalTrials.gov: NCT01811472 ↗Enrolled (actual)
52
Serious AEs
10.7%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 — 0.00; -1.68; -2.89 Percentage of liver fat — p=0.3128
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCQ908 (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24 |
0.00; -1.68; -2.89 | 0.3128 |
| SECONDARY Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12 |
-0.80; -1.71; -2.98 | — |
| SECONDARY Percentage of Responders at Week 12 |
10.00; 18.18; 31.58; 5.00; 0.00; 21.05 | — |
| SECONDARY Percentage of Responders at Week 24 |
10.53; 30.00; 35.29; 0.00; 0.00; 17.65 | — |
| SECONDARY Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6 |
-2.6; 1.4; -9.1; 2.9; 4.7; -2.5 | — |
| SECONDARY Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12 |
-0.6; 2.9; -3.7; 5.7; 8.9; -0.1 | — |
| SECONDARY Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24 |
-5.3; -1.0; -10.0; -1.8; 2.5; -3.2 | — |
| SECONDARY Percentage of Patients With Normalized Liver Enzymes |
10.0; 0.0; 10.0; 85.0; 90.9; 85.0 | — |
| SECONDARY Percent Change From Baseline in Fasting Triglycerides |
-14.6; -16.0; 3.2; -7.3; -7.9; -15.8 | — |
| SECONDARY Post-prandial Peak Triglycerides Over 0 - 8 Hours |
394.0; 370.2; 375.9; 336.0; 309.7; 374.1 | — |
| SECONDARY Change From Baseline in Body Weight |
-1.3; -2.2; -2.4; -1.1; -2.8; -2.5 | — |
| SECONDARY Change From Baseline in Waist Circumference |
-0.4; -3.7; -4.2; -1.7; -3.7; -4.2 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability |
14; 9; 20; 3; 1; 2 | — |
Summary
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).
Eligibility Criteria
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 45 Kg/m2.
Other protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01811472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.