A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
Condition: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH - Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: MSDC-0602K; Placebo
Intervention description: MSDC-0602K capsules; Placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 392.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NASH

Summary:

      This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given
      orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.
    

Eligibility criteria:

        Selected Inclusion Criteria:

          -  Adult subjects 18 years of age or greater

          -  Histological evidence of NASH, based on biopsy, with a NAS (NASH CRN scoring) ≥ 4 with
             a score of at least 1 in each component of NAS.

          -  Histological evidence of liver fibrosis defined as NASH CRN System fibrosis score F1
             to F3.

          -  Subjects with type 2 diabetes mellitus (DM) must be under stable and reasonable
             control.

          -  Male and female subjects who are taking Vitamin E should be on a stable dose of
             Vitamin E (if ≥ 400 IU) for a period of at least 3 months prior to randomization.

          -  Females should be either postmenopausal (at least 12 months since last menses) or
             surgically sterilized (bilateral tubal ligation or hysterectomy). Males with female
             partners of child-bearing potential must agree to use adequate contraceptive methods
             (including a condom, plus one other form of contraception) if engaging in sexual
             intercourse.

          -  Willing and able to sign an informed consent document indicating understanding the
             purpose of and procedures required for the study and willingness to participate in the
             study.

        Selected Exclusion Criteria:

          -  Known history of HIV.

          -  Prior liver transplantation.

          -  Other well-documented causes of active chronic liver disease.

          -  History of cirrhosis and/or hepatic decompensation including ascites, hepatic
             encephalopathy or variceal bleeding.

          -  History of alcohol abuse or drug abuse within 6 months of Screening.

          -  Type 1 diabetes mellitus.

          -  Current or history of recent (≤ 6 months) use of ursodeoxycholic acid.

          -  Use of concomitant medications with a known significant metabolism by CYP2C8 or
             CPY2C9.

          -  History of diabetic ketoacidosis or hyperosmolar non-ketotic coma within 6 months
             prior to randomization.

          -  History of heart failure (including CHF) or previous cardiovascular event (myocardial
             infarct, by-pass surgery, or PTCA) within the past 6 months prior to randomization.

          -  Blood pressure greater than 160/100 mmHg.

          -  Participation in an investigational study or received an investigational drug within
             30 days or 5 half-lives (whichever is longer) prior to study drug administration.

          -  Malignancy, including leukemia and lymphoma (excluding basal cell and squamous skin
             cell cancers and localized prostrate cancer) treated within the last 2 years.