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

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Cirius Therapeutics, Inc.; Octeta Therapeutics, LLC
• Collaborators: Chiltern International Inc.; Covance

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.