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

• Status: Completed
• Trial end date: 2019-11-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the effects of LIK066 on a variety of metabolic and inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Licogliflozin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

• 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