NCT03970031

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

Status unknown Phase 3 Last updated 8 July 2021

What this trial tests

Phase 3 trial testing MSDC-0602K in Type2 Diabetes in 1,800 participants. Status unknown.

Timeline

1 June 2022

Primary endpoint
1 September 2024

1 September 2024

Quick facts

Lead sponsor	Cirius Therapeutics, Inc.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,800
Start date	1 June 2022
Primary completion	1 September 2024
Estimated completion	1 September 2024

Drugs / interventions tested

• MSDC-0602K — full drug profile →
• Placebo

Conditions studied

• Type2 Diabetes — all drugs for Type2 Diabetes →
• NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →
• Nonalcoholic Steatohepatitis — all drugs for Nonalcoholic Steatohepatitis →
• Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →

Sponsor

Cirius Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Type2 Diabetes or NASH - Nonalcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in glycosylated hemoglobin (HbA1c) from baseline to Week 26
  Time frame: 26 weeks
• Change in the weighted average of standardized AST, CK-18, and HbA1c values (standard deviations) from baseline to Week 26
  Time frame: 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

Sponsor's own description

This is a randomized, double-blind study of MSDC-0602K or placebo in subjects with pre-T2D or T2D and evidence of NAFLD/NASH.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting fibrosis, mechanisms and cilinical trials.
   Zhao M, Wang L, Wang M, Zhou S, et al · · 2022 · cited 352× · PMID 35773269 · DOI 10.1038/s41392-022-01070-3
2. Advancements in the treatment of non-alcoholic fatty liver disease (NAFLD).
   Rong L, Zou J, Ran W, Qi X, et al · · 2022 · cited 180× · PMID 36726464 · DOI 10.3389/fendo.2022.1087260
3. Combination therapy for non-alcoholic steatohepatitis: rationale, opportunities and challenges.
   Dufour JF, Caussy C, Loomba R. · · 2020 · cited 145× · PMID 32381514 · DOI 10.1136/gutjnl-2019-319104
4. Nonalcoholic fatty liver disease as a metabolic disease in humans: A literature review.
   Cariou B, Byrne CD, Loomba R, Sanyal AJ. · · 2021 · cited 133× · PMID 33464677 · DOI 10.1111/dom.14322
5. Metabolic liver disease in diabetes - From mechanisms to clinical trials.
   Dewidar B, Kahl S, Pafili K, Roden M. · · 2020 · cited 96× · PMID 32569680 · DOI 10.1016/j.metabol.2020.154299
6. Nonalcoholic Fatty Liver Disease (NAFLD). Mitochondria as Players and Targets of Therapies?
   Di Ciaula A, Passarella S, Shanmugam H, Noviello M, et al · · 2021 · cited 93× · PMID 34065331 · DOI 10.3390/ijms22105375
7. Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease.
   Fraile JM, Palliyil S, Barelle C, Porter AJ, et al · · 2021 · cited 91× · PMID 34588764 · DOI 10.2147/dddt.s315724
8. Pharmacological advances in mitochondrial therapy.
   Singh A, Faccenda D, Campanella M. · · 2021 · cited 88× · PMID 33647769 · DOI 10.1016/j.ebiom.2021.103244