Phase 2
N=392
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
Non-alcoholic Fatty Liver Disease · Non-alcoholic Steatohepatitis · NASH - Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT02784444 ↗Enrolled (actual)
392
Serious AEs
8.7%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants With Hepatic Histological Improvement in NAS — 22; 25; 27; 34 Participants — p=0.747
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MSDC-0602K (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cirius Therapeutics, Inc.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hepatic Histological Improvement in NAS |
22; 25; 27; 34 | 0.747 |
| SECONDARY Number of Subjects With Resolution of NASH With no Worsening of Fibrosis at 12 Months. |
15; 17; 23; 27 | 0.828 |
| SECONDARY Number of Subjects With Improvement of Fibrosis (CRN Staging Score) by at Least 1 Stage With no Worsening of NASH at 12 Months. |
16; 20; 23; 25 | 0.657 |
| SECONDARY Mean Change From Baseline in NAFLD Activity Score (NAS) |
-0.6; -1.0; -1.1; -1.2 | 0.392 |
| SECONDARY Mean Change From Baseline in CRN Steatosis Score |
-0.4; -0.6; -0.5; -0.7 | 0.224 |
| SECONDARY Mean Change From Baseline in CRN Inflammation Score |
-0.1; -0.1; -0.2; -0.1 | 0.488 |
| SECONDARY Mean Change From Baseline in CRN Ballooning Score |
-0.2; -0.4; -0.4; -0.4 | 0.416 |
| SECONDARY Mean Change From Baseline in CRN Fibrosis Staging Score |
0.0; 0.1; -0.1; -0.1 | 0.928 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02784444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.