Effect of LIK066 on reduction of fatty content in livers of obese patients
- Conditions
- obese patients with non-alcoholic steatohepatitis (NASH)MedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2017-002046-71-NL
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 107
EITHER
Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.
OR
Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:
-ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
-BMI greater than or equal to 27 kg/m^2 (in patients with a self-identified race other than Asian) or greater than or equal
to 23 kg/m^2 (in patients with a self identified Asian race) AND
-Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%.
Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
Male and female patients 18 years or older at the time of screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
- History or presence of other concomitant liver diseases.
- History or current diagnosis of ECG abnormalities.
- Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study.
- Patients with contraindications to MRI imaging.
- Current or history of significant alcohol consumption.
- Clinical evidence of hepatic decompensation or severe liver impairment.
- Women of child bearing potential (unless on basic contraception methods).
- Presence of liver cirrhosis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of LIK066 on alanine aminotransferase (ALT) after 12 weeks of treatment;Secondary Objective: - To determine the effect of LIK066 on intrahepatic lipid after 12 weeks of treatment as measured by MRI<br>- To determine the effect of LIK066 on total body weight after 12 weeks of treatment<br>- To determine the effect of LIK066 on non-invasive markers of liver fibrosis after 12 weeks of treatment<br>- To determine the safety and tolerability of LIK066 <br>- To evaluate the pharmacokinetics (PK) of LIK066 in NASH patients<br>- To determine the effect of LIK066 on aspartate aminotransferase (AST) after 12 weeks of treatment;Primary end point(s): Change from baseline in ALT at week 12;Timepoint(s) of evaluation of this end point: Baseline, week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change from baseline in percent liver fat at week 12<br>- Change from baseline in total body weight at week 12<br>- Change from baseline on non-invasive liver fibrosis markers (Enhanced Liver Fibrosis (ELF) panel) at week 12<br>- Change from baseline in Aspartate aminotransferase (AST) at week 12<br>Pharmacokinetic End points:<br>- Observed maximum time duration of maximum concentration (Tmax) following drug administration<br>- Observed area under the curve up to the last measurable concentration (AUClast) following drug administration<br>- Observed maximum plasma concentration (Cmax) following drug administration<br>Safety and tolerability:<br>- Adverse events, safety laboratory tests including basic chemistry profile and liver biochemical tests;Timepoint(s) of evaluation of this end point: Baseline, week 12<br>Pharmacokinetic end points : Day 56 (0, 1,2, 4 and 6 hrs post dose)<br>