A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
NCT ID: NCT02784444
Last Updated: 2020-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
392 participants
INTERVENTIONAL
2016-09-14
2019-06-30
Brief Summary
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Detailed Description
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Safety will be assessed by monitoring of vital signs, 12 lead electrocardiogram (ECG), physical examinations, safety labs, and adverse events (AEs).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MSDC-0602K Dose 1 capsules
MSDC-0602K Dose 1 capsule taken once daily for 360 days
MSDC-0602K
MSDC-0602K capsules
MSDC-0602K Dose 2 capsules
MSDC-0602K Dose 2 capsules taken once daily for 360 days
MSDC-0602K
MSDC-0602K capsules
MSDC-0602K Dose 3 capsules
MSDC-0602K Dose 3 capsules taken once daily for 360 days
MSDC-0602K
MSDC-0602K capsules
Placebo capsules
Matching Placebo capsule taken once daily for 360 days
Placebo
Placebo capsules
Interventions
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MSDC-0602K
MSDC-0602K capsules
Placebo
Placebo capsules
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Chiltern International Inc.
INDUSTRY
Cirius Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Dittrich, MD
Role: STUDY_DIRECTOR
Cirius Therapeutics, Inc.
Locations
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Chandler, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Fresno, California, United States
Garden Grove, California, United States
Huntington Park, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Poway, California, United States
Rialto, California, United States
San Diego, California, United States
Englewood, Colorado, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Inverness, Florida, United States
Lakewood Rch, Florida, United States
Miami Lakes, Florida, United States
Wellington, Florida, United States
Marietta, Georgia, United States
Indianapolis, Indiana, United States
Bastrop, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
West Monroe, Louisiana, United States
Flowood, Mississippi, United States
Brooklyn, New York, United States
New York, New York, United States
Fayetteville, North Carolina, United States
Greenville, North Carolina, United States
Statesville, North Carolina, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Hermitage, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Fort Sam Houston, Texas, United States
Houston, Texas, United States
Live Oak, Texas, United States
Rollingwood, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Countries
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References
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Harrison SA, Alkhouri N, Davison BA, Sanyal A, Edwards C, Colca JR, Lee BH, Loomba R, Cusi K, Kolterman O, Cotter G, Dittrich HC. Insulin sensitizer MSDC-0602K in non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled phase IIb study. J Hepatol. 2020 Apr;72(4):613-626. doi: 10.1016/j.jhep.2019.10.023. Epub 2019 Nov 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MSDC-0602K-C009NASH
Identifier Type: -
Identifier Source: org_study_id
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