A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH (EMMINENCE)

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring NASH Read More

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.