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Non-alcoholic Fatty Liver DiseasePhase 2EMMINENCENCT02784444

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

A Phase 2 study testing MSDC-0602K in people with Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Cirius Therapeutics, Inc. at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MSDC-0602K
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
43 sitesUnited States
Study dates
14 Sep 2016to Jun 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Study site

    Arlington, Texas, 76012

  • Study site

    Bastrop, Louisiana, 71220

  • Study site

    Brooklyn, New York, 112301

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Chula Vista, California, 91910

  • Study site

    Dallas, Texas, 75203

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Fort Sam Houston, Texas, 78234

  • Study site

    Fresno, California, 93701

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Garden Grove, California, 92844

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Hermitage, Tennessee, 37076

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Houston, Texas, 77030

  • Study site

    Huntington Park, California, 90255

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Inverness, Florida, 34452

  • Study site

    La Mesa, California, 91942

  • Study site

    Lakewood Rch, Florida, 34211

  • Study site

    Live Oak, Texas, 78233

  • Study site

    Los Angeles, California, 90036

  • Study site

    Los Angeles, California, 90057

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami Lakes, Florida, 33016

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New York, New York, 10018

  • Study site

    Poway, California, 92064

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Rialto, California, 92377

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Rollingwood, Texas, 78746

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78265

  • Study site

    San Diego, California, 92103

  • Study site

    Statesville, North Carolina, 28677

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Wellington, Florida, 33414

  • Study site

    West Monroe, Louisiana, 71291

Other trials in United States

About this study

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™)

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.

Read the 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).

Being tested
MSDC-0602K, Placebo
Keywords
NASH
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MSDC-0602KDrug

    MSDC-0602K capsules

  • PlaceboDrug

    Placebo capsules

Study groups in NCT02784444
Study groupRoleWhat they receive
MSDC-0602K Dose 1 capsulesActive comparatorMSDC-0602K Dose 1 capsule taken once daily for 360 days
Receives: Drug: MSDC-0602K
MSDC-0602K Dose 2 capsulesActive comparatorMSDC-0602K Dose 2 capsules taken once daily for 360 days
Receives: Drug: MSDC-0602K
MSDC-0602K Dose 3 capsulesActive comparatorMSDC-0602K Dose 3 capsules taken once daily for 360 days
Receives: Drug: MSDC-0602K
Placebo capsulesPlacebo comparatorMatching Placebo capsule taken once daily for 360 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months (360 days)

Secondary outcomes (7)

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

    • CRN ballooning score of 0 at 12-months
    • CRN inflammation score of 0 or 1 at 12-months
    • No increase in CRN fibrosis score from baseline to 12-months

    Measured: 12 months (360 days)

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

    • Decrease in fibrosis CRN staging score of >= 1 full stage from baseline to 12 months
    • No increase in ballooning CRN score from baseline to 12 months
    • No increase in inflammation CRN score from baseline to 12-months

    Measured: 12 months (360 days)

  3. Mean Change From Baseline in NAFLD Activity Score (NAS)

    NAS is the sum of the scores of steatosis, inflammation, and ballooning. It has a range of 0 to 8 with higher scores indicating worse disease severity.

    Measured: 12 months (360 days)

  4. Mean Change From Baseline in CRN Steatosis Score

    Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis.

    Measured: 12 months (360 days)

  5. Mean Change From Baseline in CRN Inflammation Score

    Inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe inflammation.

    Measured: 12 months (360 days)

  6. Mean Change From Baseline in CRN Ballooning Score

    Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning.

    Measured: 12 months (360 days)

  7. Mean Change From Baseline in CRN Fibrosis Staging Score

    Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.

    Measured: 12 months (360 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2016 (estimated)
  2. Study start14 Sep 2016
  3. Primary completionJun 2019
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784444
Sponsor's protocol ID
MSDC-0602K-C009NASH
Acronym
EMMINENCE
Status last verified
Aug 2020
First submitted
18 May 2016
Last updated
16 Sep 2020
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31697972

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MSDC-0602K in people with Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by Cirius Therapeutics, Inc. at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Hepatic Histological Improvement in NAS (time frame: 12 months (360 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02784444, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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