NCT02784444: EMMINENCE

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Month, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602K in Patients With NASH (EMMINENCE™)

Completed Phase 2 Results posted Last updated 28 August 2020

What this trial tests

Phase 2 trial testing MSDC-0602K in Non-alcoholic Fatty Liver Disease in 392 participants. Completed in 1 June 2019.

Timeline

14 September 2016

Primary endpoint
1 June 2019

1 June 2019

Quick facts

Lead sponsor	Cirius Therapeutics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	392
Start date	14 September 2016
Primary completion	1 June 2019
Estimated completion	1 June 2019
Sites	43 locations across United States

Drugs / interventions tested

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

Conditions studied

• Non-alcoholic Fatty Liver Disease — all drugs for Non-alcoholic Fatty Liver Disease →
• Non-alcoholic Steatohepatitis — all drugs for Non-alcoholic Steatohepatitis →
• NASH - Nonalcoholic Steatohepatitis — all drugs for NASH - Nonalcoholic Steatohepatitis →

Sponsor

Cirius Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-alcoholic Fatty Liver Disease or Non-alcoholic 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.

• Number of Participants With Hepatic Histological Improvement in NAS
  Time frame: 12 months (360 days)
  * A decrease of at least 2 points in NAS at 12 months. * At least a 1 point reduction in either ballooning or inflammation from baseline to 12 months. * no increase in CRN fibrosis score (i.e., an increase of 1 stage or more) from baseline to 12 months.

Sponsor's own description

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.

Publications & conference data

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

1. Mechanisms of NAFLD development and therapeutic strategies.
   Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. · · 2018 · cited 3203× · PMID 29967350 · DOI 10.1038/s41591-018-0104-9
2. Current and future pharmacological therapies for NAFLD/NASH.
   Sumida Y, Yoneda M. · · 2018 · cited 487× · PMID 29247356 · DOI 10.1007/s00535-017-1415-1
3. PPARs and nonalcoholic fatty liver disease.
   Liss KH, Finck BN. · · 2017 · cited 226× · PMID 27916647 · DOI 10.1016/j.biochi.2016.11.009
4. Insulin sensitizer MSDC-0602K in non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled phase IIb study.
   Harrison SA, Alkhouri N, Davison BA, Sanyal A, et al · · 2020 · cited 176× · PMID 31697972 · DOI 10.1016/j.jhep.2019.10.023
5. 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
6. Therapeutic targets, novel drugs, and delivery systems for diabetes associated NAFLD and liver fibrosis.
   Kumar V, Xin X, Ma J, Tan C, et al · · 2021 · cited 128× · PMID 34314787 · DOI 10.1016/j.addr.2021.113888
7. Targeting the mitochondrial pyruvate carrier attenuates fibrosis in a mouse model of nonalcoholic steatohepatitis.
   McCommis KS, Hodges WT, Brunt EM, Nalbantoglu I, et al · · 2017 · cited 126× · PMID 28027586 · DOI 10.1002/hep.29025
8. Metabolic Targets in Nonalcoholic Fatty Liver Disease.
   Esler WP, Bence KK. · · 2019 · cited 105× · PMID 31004828 · DOI 10.1016/j.jcmgh.2019.04.007