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

UNKNOWNPHASE3

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

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

NCT03970031•Cirius Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This is a randomized, double-blind study of MSDC-0602K or placebo given orally once daily to subjects with pre-T2D or T2D and evidence of NAFLD/NASH. Visits will include a Screening Period, a minimum Treatment of 26 weeks, and a Long-Term Follow-up Period during which subjects will continue taking assigned treatment. Safety will be assessed by periodic measurement of vital signs, physical examinations, blood laboratory analyses, and the occurrence of adverse events.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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

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.
+13 more criteria

Key Dates

Start Date

June 1, 2022

Primary Completion Date

September 1, 2024

Completion Date

September 1, 2024

Last Updated

July 12, 2021

Enrollment

1,800

ESTIMATED participants

Conditions

Type2 DiabetesNASH - Nonalcoholic SteatohepatitisNonalcoholic SteatohepatitisNon-Alcoholic Fatty Liver Disease

Interventions

MSDC-0602K

DRUG

Placebo

DRUG

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

NCT02815891

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

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RECRUITINGNA

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

NCT03587831

NASH - Nonalcoholic Steatohepatitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

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