A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH

NCT03970031
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Phase
Phase 3
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Recruitment status
Unknown
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Participants
1,800
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Lead sponsor
Cirius Therapeutics, Inc.
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Start date
2022-06-01
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Summary
This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.
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Short title
A Study of MSDC-0602K to Assess Glycemic Control and Cardiovascular Outcomes in Patients With Pre-T2D or T2D and NAFLD/NASH
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Official title
MMONARCh-1: Study of MSDC-0602K, a Modulator of the Mitochondrial Pyruvate Carrier for Outcomes in Patients With Pre Type 2 Diabetes (T2D) or T2D and NAFLD/NASH, Assessed for ImpRoved Glycemic Control and Cardiovascular Outcomes-1
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-09-01
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First posted
2019-05-31
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Registry last updated
2021-07-12
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Primary completion date
2024-09-01
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Start date
2022-06-01
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Participants
1,800
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Participant count basis
Estimated
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Planned participants
1,800
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Protocol amendments
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Cirius Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT03970031
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ClinicalTrials.gov ID
NCT03970031
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26

    Timeframe: 26 weeks

  2. Change in the weighted average of standardized AST, CK-18, and HbA1c values (standard deviations) from baseline to Week 26

    Timeframe: 26 weeks

    This is a single composite outcome measure. This is derived by standardizing the values of AST, CK-18, and HbA1c by subtracting the respective study population means and dividing by respective study population standard deviations at each time point; averaging these standardized AST, CK-18,and HbA1c values (or z-scores) for a given patient at each time point; and then computing the difference from baseline to week 26 with respect to these averages.

  1. Time to first event of death, adjudicated nonfatal MI or USA hospitalization, adjudicated hospital admission for HF, or adjudicated nonfatal ischemic stroke.

    Timeframe: through study completion, an expected average of 15 months

  2. Time to first event of death or adjudicated non-fatal MI or USA hospitalization, adjudicated hospital admission for HF, adjudicated nonfatal ischemic stroke, or liver event in all randomized subjects.

    Timeframe: through study completion, an expected average of 15 months

    A liver event consists of ascites (confirmed by paracentesis or abdominal imaging), hepatic encephalopathy (defined clinically), variceal hemorrhage (confirmed by endoscopy), or liver transplant.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

Key Inclusion Criteria:

  1. Written informed consent.

  2. Adult subjects with an age of > 18 years but < 80 years.

  3. Male or female subjects with reproductive potential must agree to comply with approved double barrier contraceptive method for the duration of the trial. Females of non-childbearing potential are considered:

    Post-menopausal Surgically sterile

  4. Diagnosis of NAFLD

  5. AST>27 U/L

  6. HgbA1c >6%

  7. Diagnosis of Pre-T2D or T2D

  8. History of macrovascular cardiovascular disease

Key Exclusion Criteria:

  1. Prior liver transplantation or currently on transplant list.
  2. Other well-documented causes of active chronic liver disease
  3. Current cirrhosis
  4. Pregnant or nursing women
  5. AST or ALT > 5 times the upper limit of normal
  6. Total bilirubin > 1.3 mg/dL unless diagnosis of Gilbert's disease with direct bilirubin within normal reference range
  7. Serum albumin < 3.5 g/dL at Screening
  8. Alkaline phosphatase >2 times the upper limit of normal at Screening
  9. Estimated glomerular filtration rate (eGFR by MDRD) <30 ml/min/1.73 m2 but ≤75 ml/min/1.73 m2
  10. In patients who are not anticoagulated, INR ≥ 1.3 times ULN at Screening or other evidence of impaired coagulation.
  11. Acute vascular events including ACS, stroke or TIA, worsening of peripheral vascular disease or any vascular/cardiac procedure
  12. Limb amputation for reason other than trauma.
  13. HbA1c >10%
  14. Any planned surgery or device implantation after screening
  15. Ejection fraction < 35% or Heart failure with NYHA class IV
  16. History of alcohol abuse or drug abuse within 6 months prior to Screening Diagnosis at any time of Type 1 diabetes.
  17. Current or history of recent (≤ 6 months) use of ursodeoxycholic acid.
  18. Current use of insulin.
  19. Current use of thiazolidinediones.
  20. Any history or current concomitant disorder such as haematological, pulmonary, metabolic, endocrine disorders that are severe or life-threatening.
  21. Use of concomitant medications with a known significant metabolism by CYP2C8 including paclitaxel or repaglinide for the duration of the study.
  22. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma within the 6 months prior to Screening.
  23. Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds such as PPARγ agonists (pioglitazone or rosiglitazone), or any of their stated ingredients.
Sources for eligibility
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (5)

Targets (1)