A Study of MSDC-0602K to Assess Glycemic Control, Resolution of NASH, and Outcomes in Patients With Diabetes and NASH
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|ClinicalTrials.gov Identifier: NCT03970031|
Recruitment Status : Not yet recruiting
First Posted : May 31, 2019
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type2 Diabetes NASH - Nonalcoholic Steatohepatitis Nonalcoholic Steatohepatitis Non-Alcoholic Fatty Liver Disease||Drug: MSDC-0602K Drug: Placebo oral tablet||Phase 3|
This is a randomized, double-blind study of MSDC-0602K or placebo given orally once daily to subjects with type 2 diabetes and evidence of NASH. Visits to the clinic will be at baseline, 1, 3, and every 3 months thereafter until the study is terminated.
Safety will be assessed by periodic measurement of vital signs, physical examinations, blood laboratory analyses, and the occurrence of adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||MMONARCh: Study of MSDC-0602K, a Modulator of the Mitochondrial Pyruvate Carrier for Outcomes in Patients With NASH and Diabetes, Assessed for Resolution of NASH and Improved Glycemic Control|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: MSDC-0602K Tablet
MSDC-0602K Dose 1 taken one tablet per day orally
Placebo Comparator: Placebo Tablet
Matching placebo taken one tablet per day orally
Drug: Placebo oral tablet
- Mean change in glycosylated hemoglobin (HbA1c) from Baseline to 6 months follow-up in the first 800 subjects randomized with poorly controlled T2D [ Time Frame: 6 months ]Mean change in glycosylated hemoglobin (HbA1c) from Baseline (Baseline HbA1c is defined as the average of HbA1c values from Screening 2 and Randomization) to 6 months follow-up in the first 800 subjects randomized in the stratum of poorly controlled T2D (defined as average Screening HbA1c > 7.0%) with baseline (average Screening 2 and Randomization) HbA1c > 7.0% who have reached 6-month follow-up.
- Biopsy-confirmed hepatic histological resolution of NASH as evidenced by ALL of the following at 12 months: o Inflammation score of 0-1; o Ballooning score of 0; o At least a 2-point improvement (decrease) in the NAS; and o NO worsening of fibrosis [ Time Frame: 12 months ]
Biopsy-confirmed hepatic histological resolution of NASH as evidenced by ALL of the following at 12 months:
- Inflammation score of 0-1;
- Ballooning score of 0;
- At least a 2-point improvement (decrease) in the NAS; and
- No worsening of fibrosis defined as no increase in CRN fibrosis score
in the first 1000 subjects randomized into the NASH histology stratum with NASH criteria confirmed by central histopathology.
- Time to first event of Death or Hepatic and/or Major Adverse Cardiac Events [ Time Frame: 31 months ]Time to first event of Death or Hepatic and/or Major Adverse Cardiac Events in all randomized subjects