Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients
Condition: Obese Patients With Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: LIK066; Placebo
Intervention description: Film coated tablet of LIK066 either 30mg or 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84; LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-alcoholic steatohepatitis; NASH; Obese; Type 2 diabetes mellitus; non-alcoholic fatty liver disease

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)
    

Eligibility 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