A Phase 2 interventional study of Placebo and ECC4703 in Metabolic Dysfunction-associated Steatohepatitis, sponsored by Eccogene. Recruiting at 64 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Eccogene · Phase 2, Interventional, and Treatment
The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.
2,081 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's planned enrollment of 160 is above the median of 50 across 1,322 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Eccogene is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: ECC4703
Drug: ECC4703
Drug: ECC0509 · Drug: ECC4703
Drug: ECC0509
Drug: ECC0509
Placebo will be administered as matching oral capsules.
ECC4703 will be administered as oral capsules.
ECC0509 will be administered as oral capsules.
ECC4703 will be administered as oral capsules.
Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo
Time frame: Baseline and Week 12
Absolute Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo
Time frame: Baseline and Week 12
Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Absolute Change From Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Percentage of Participants With ≥30%, ≥50%, and ≥70% Relative Reduction and Normalization (<5%) in Liver Fat Content by MRI-PDFF, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change From Baseline in Alanine Aminotransferase (ALT), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Percentage of Participants Achieving ≥17-unit Reduction in ALT, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Week 12
Percentage of Participants With 30% Reduction in MRI-PDFF, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Week 12
Change from Baseline in Aspartate Aminotransferase (AST), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in Alkaline Phosphatase (ALP), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in Gamma-glutamyl Transferase (GGT), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in Fibrosis-4 Index (FIB-4), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in AST to Platelet Ratio Index (APRI), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in FibroScan AST Score (FAST), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in MASH Resolution Index, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time frame: Baseline and Week 12
Change from Baseline in Total Cholesterol (TC), Triglycerides (TG), High-density Lipoprotein (HDL), Low-density Lipoprotein (LDL) and Apoprotein B (ApoB)
Time frame: Baseline to Week 12
Change from Baseline in Lipoprotein(a) (Lp[a]) Profiles
Time frame: Baseline to Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 12
Change from Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline to Week 12
Change from Baseline in Fasting Insulin
Time frame: Baseline to Week 12
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Profiles
Time frame: Baseline to Week 12
Change from Baseline in Body Weight
Time frame: Baseline to Week 12
Change from Baseline Body Mass Index (BMI)
Time frame: Baseline to Week 12
Change from Baseline in Plasma Methylamine
Time frame: Baseline to Week 12
Change from Baseline in Cytokeratin-18 (CK-18)
Time frame: Baseline to Week 12
Change from Baseline in C-telopeptide of Type III Collagen (CTX-III)
Time frame: Baseline to Week 12
Change from Baseline in N-terminal Pro-peptide of Type III Collagen (Pro-C3)
Time frame: Baseline to Week 12
Change in Ratio of Pro-C3
Time frame: Week 12
Change in Ratio of CTX-III
Time frame: Week 12
Change from Baseline in Chronic Liver Disease Questionnaire (CLDQ)
Time frame: Baseline and Week 12
Change from Baseline in Short-form Liver Disease Quality of Life (SF-LDQOL)
Time frame: Baseline to Week 12
Plasma Concentration of ECC4703 and ECC0509
Time frame: Day 1, Weeks 2, 4, 6, 8, and 12
Plan to share: No
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