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

NCT02784444 | Completed Phase 2 Results

• 1 other identifier: MSDC-0602K-C009NASH
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 43

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.

Conditions

Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH - Nonalcoholic Steatohepatitis

Keywords

NASH

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hepatic Histological Improvement in NAS

  * A decrease of at least 2 points in NAS at 12 months. * At least a 1 point reduction in either ballooning or inflammation from baseline to 12 months. * no increase in CRN fibrosis score (i.e., an increase of 1 stage or more) from baseline to 12 months.

  12 months (360 days)

Secondary Outcomes (7)

• Number of Subjects With Resolution of NASH With no Worsening of Fibrosis at 12 Months.

  12 months (360 days)

• Number of Subjects With Improvement of Fibrosis (CRN Staging Score) by at Least 1 Stage With no Worsening of NASH at 12 Months.

  12 months (360 days)

• Mean Change From Baseline in NAFLD Activity Score (NAS)

  12 months (360 days)

• Mean Change From Baseline in CRN Steatosis Score

  12 months (360 days)

• Mean Change From Baseline in CRN Inflammation Score

  12 months (360 days)

Study Arms (4)

MSDC-0602K Dose 1 capsules

ACTIVE COMPARATOR

MSDC-0602K Dose 1 capsule taken once daily for 360 days

Drug: MSDC-0602K

MSDC-0602K Dose 2 capsules

ACTIVE COMPARATOR

MSDC-0602K Dose 2 capsules taken once daily for 360 days

Drug: MSDC-0602K

MSDC-0602K Dose 3 capsules

ACTIVE COMPARATOR

MSDC-0602K Dose 3 capsules taken once daily for 360 days

Drug: MSDC-0602K

Placebo capsules

PLACEBO COMPARATOR

Matching Placebo capsule taken once daily for 360 days

Drug: Placebo

Interventions

MSDC-0602K DRUG

MSDC-0602K capsules

MSDC-0602K Dose 1 capsules; MSDC-0602K Dose 2 capsules; MSDC-0602K Dose 3 capsules

Placebo DRUG

Placebo capsules

Placebo capsules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cirius Therapeutics, Inc.: lead
• Chiltern International Inc.: collaborator

Study Sites (43)

Unknown Facility

Chandler, Arizona, 85224, United States

Location

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Tucson, Arizona, 85712, United States

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Chula Vista, California, 91910, United States

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Fresno, California, 93701, United States

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Garden Grove, California, 92844, United States

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Huntington Park, California, 90255, United States

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La Mesa, California, 91942, United States

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Los Angeles, California, 90036, United States

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Los Angeles, California, 90057, United States

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Poway, California, 92064, United States

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Rialto, California, 92377, United States

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San Diego, California, 92103, United States

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Englewood, Colorado, 80113, United States

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Gainesville, Florida, 32610, United States

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Hialeah, Florida, 33016, United States

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Inverness, Florida, 34452, United States

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Lakewood Rch, Florida, 34211, United States

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Miami Lakes, Florida, 33016, United States

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Wellington, Florida, 33414, United States

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Marietta, Georgia, 30060, United States

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Indianapolis, Indiana, 46202, United States

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Bastrop, Louisiana, 71220, United States

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New Orleans, Louisiana, 70112, United States

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New Orleans, Louisiana, 70115, United States

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West Monroe, Louisiana, 71291, United States

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Flowood, Mississippi, 39232, United States

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Brooklyn, New York, 112301, United States

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New York, New York, 10018, United States

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Fayetteville, North Carolina, 28304, United States

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Greenville, North Carolina, 27834, United States

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Statesville, North Carolina, 28677, United States

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Providence, Rhode Island, 02905, United States

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Germantown, Tennessee, 38138, United States

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Hermitage, Tennessee, 37076, United States

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Arlington, Texas, 76012, United States

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Dallas, Texas, 75203, United States

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Fort Sam Houston, Texas, 78234, United States

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Houston, Texas, 77030, United States

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Live Oak, Texas, 78233, United States

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Rollingwood, Texas, 78746, United States

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San Antonio, Texas, 78215, United States

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Unknown Facility

San Antonio, Texas, 78265, United States

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Richmond, Virginia, 23249, United States

Location

Related Publications (1)

• 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.

  PMID: 31697972 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Jules Lee
• Organization: Cirius Therapeutics Inc.

jlee@ciriustx.com

8583336274

Study Officials

• Howard Dittrich, MD

  Cirius Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 27, 2016
• Study Start: September 14, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 16, 2020
• Results First Posted: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (43)