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

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ClinicalTrials.gov Identifier: NCT02784444
Recruitment Status : Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Cirius Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis NASH - Nonalcoholic Steatohepatitis Drug: MSDC-0602K Drug: Placebo Phase 2

Detailed Description:

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. Visits to the clinic will be at baseline, 1, 2, 3, 6, 9, and 12 months, with one 2- week follow-up visit.

Safety will be assessed by monitoring of vital signs, 12 lead electrocardiogram (ECG), physical examinations, safety labs, and adverse events (AEs).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Month, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC 0602K in Patients With NASH (EMMINENCE™)
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Active Comparator: MSDC-0602K Dose 1 capsules
MSDC-0602K Dose 1 capsule taken once daily for 360 days
Drug: MSDC-0602K
MSDC-0602K capsules

Active Comparator: MSDC-0602K Dose 2 capsules
MSDC-0602K Dose 2 capsules taken once daily for 360 days
Drug: MSDC-0602K
MSDC-0602K capsules

Active Comparator: MSDC-0602K Dose 3 capsules
MSDC-0602K Dose 3 capsules taken once daily for 360 days
Drug: MSDC-0602K
MSDC-0602K capsules

Placebo Comparator: Placebo capsules
Matching Placebo capsule taken once daily for 360 days
Drug: Placebo
Placebo capsules




Primary Outcome Measures :
  1. Hepatic histological improvement in NAS defined as a decrease of at least 2 points with no worsening of fibrosis stage at 12 months. [ Time Frame: 12 months (360 days) ]

Secondary Outcome Measures :
  1. Proportion of subjects with resolution of NASH with no worsening of fibrosis at 12 months. [ Time Frame: 12 months (360 days) ]
  2. Proportion of subjects with improvement of fibrosis (CRN staging score) by at least 1 stage with no worsening of NASH at 12 months. [ Time Frame: 12 months (360 days) ]
  3. Mean change from baseline in NAFLD activity score (NAS) and each one of its components (steatosis, inflammation and ballooning) at 12 months. [ Time Frame: 12 months (360 days) ]
  4. Mean change from baseline in fibrosis score at 12 months. [ Time Frame: 12 months (360 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784444


  Show 44 Study Locations
Sponsors and Collaborators
Cirius Therapeutics, Inc.
Chiltern International Inc.
Investigators
Study Director: Howard Dittrich, MD Cirius Therapeutics, Inc.

Responsible Party: Cirius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02784444     History of Changes
Other Study ID Numbers: MSDC-0602K-C009NASH
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cirius Therapeutics, Inc.:
NASH

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases