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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| ECC4703 Low Dose | Experimental |
| |
| ECC4703 High Dose | Experimental |
| |
| ECC4703 High Dose + ECC0509 High Dose | Experimental |
| |
| ECC0509 Low Dose | Experimental |
| |
| ECC0509 High Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo will be administered as matching oral capsules. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eccogene Clinical Trials | Contact | 86-21-61053022 | contact@eccogene.com |
| Name | Affiliation | Role |
|---|---|---|
| Eccogene Clinical Trials | Eccogene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Liver Health | Recruiting | Chandler | Arizona | 85224 | United States | |
| Arizona Liver Health - Peoria |
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| ECC4703 |
| Drug |
ECC4703 will be administered as oral capsules. |
|
| ECC0509 | Drug | ECC0509 will be administered as oral capsules. |
|
| ECC4703 | Drug | ECC4703 will be administered as oral capsules. |
|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | Baseline to Week 12 |
| Change from Baseline in Lipoprotein(a) (Lp[a]) Profiles | Baseline to Week 12 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline to Week 12 |
| Change from Baseline in Fasting Plasma Glucose (FPG) | Baseline to Week 12 |
| Change from Baseline in Fasting Insulin | Baseline to Week 12 |
| Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Profiles | Baseline to Week 12 |
| Change from Baseline in Body Weight | Baseline to Week 12 |
| Change from Baseline Body Mass Index (BMI) | Baseline to Week 12 |
| Change from Baseline in Plasma Methylamine | Baseline to Week 12 |
| Change from Baseline in Cytokeratin-18 (CK-18) | Baseline to Week 12 |
| Change from Baseline in C-telopeptide of Type III Collagen (CTX-III) | Baseline to Week 12 |
| Change from Baseline in N-terminal Pro-peptide of Type III Collagen (Pro-C3) | Baseline to Week 12 |
| Change in Ratio of Pro-C3 | Week 12 |
| Change in Ratio of CTX-III | Week 12 |
| Change from Baseline in Chronic Liver Disease Questionnaire (CLDQ) | Baseline and Week 12 |
| Change from Baseline in Short-form Liver Disease Quality of Life (SF-LDQOL) | Baseline to Week 12 |
| Plasma Concentration of ECC4703 and ECC0509 | Day 1, Weeks 2, 4, 6, 8, and 12 |
| Recruiting |
| Peoria |
| Arizona |
| 85381 |
| United States |
| Adobe Clinical Research, LLC | Recruiting | Tucson | Arizona | 85712 | United States |
| Arizona Liver Health - Tucson | Recruiting | Tucson | Arizona | 85712 | United States |
| Arkansas Gastroenterology, P.A | Recruiting | Little Rock | Arkansas | 71913 | United States |
| ARcare Center for Clinical Research | Recruiting | Little Rock | Arkansas | 77205 | United States |
| Om Research | Recruiting | Apple Valley | California | 92307 | United States |
| ARK Clinical Research - Fountain Valley | Recruiting | Fountain Valley | California | 92708 | United States |
| Om Research | Recruiting | Lancaster | California | 93534 | United States |
| Ark Clinical Research | Recruiting | Long Beach | California | 90815 | United States |
| Knowledge Research Center | Recruiting | Orange | California | 92868 | United States |
| Om Research | Recruiting | Victorville | California | 92395 | United States |
| Synergy Healthcare | Recruiting | Bradenton | Florida | 33511 | United States |
| Synergy Healthcare | Recruiting | Bradenton | Florida | 34209 | United States |
| Health Awareness, Inc. | Recruiting | Jupiter | Florida | 33458 | United States |
| Evolution Clinical Trials | Recruiting | Miami | Florida | 33122 | United States |
| Floridian Clinical Research, LLC | Recruiting | Miami Lakes | Florida | 33016 | United States |
| Ocala GI Research | Recruiting | Ocala | Florida | 34471 | United States |
| Progressive Medical Research | Recruiting | Port Orange | Florida | 32127 | United States |
| ClinCloud, LLC | Recruiting | Viera | Florida | 32940 | United States |
| Metabolic Research Institute | Recruiting | West Palm Beach | Florida | 33401 | United States |
| CenExel - iResearch | Recruiting | Decatur | Georgia | 30030 | United States |
| Gastrointestinal Specialists of Georgia, PC | Recruiting | Marietta | Georgia | 30060 | United States |
| Digestive Research Alliance of Michiana | Recruiting | South Bend | Indiana | 46635 | United States |
| Tandem Clinical Research | Recruiting | Covington | Louisiana | 70433 | United States |
| Tandem Clinical Research | Recruiting | Houma | Louisiana | 70360 | United States |
| Tandem Clinical Research GI, LLC | Recruiting | Marrero | Louisiana | 70072 | United States |
| Tandem Clinical Research | Recruiting | Metairie | Louisiana | 70006 | United States |
| Delta Research Partners | Recruiting | Monroe | Louisiana | 71201 | United States |
| Louisiana Research Center, LLC | Recruiting | Shreveport | Louisiana | 71105 | United States |
| Delta Research Partners, LLC | Recruiting | West Monroe | Louisiana | 71291 | United States |
| Mid-Atlantic GI Research | Recruiting | Greenbelt | Maryland | 20770 | United States |
| Gastrointestinal Associates | Recruiting | Columbia | Missouri | 65201 | United States |
| Gateway GI Research, LLC | Recruiting | St Louis | Missouri | 63141 | United States |
| Jubilee Clinical Research, Inc | Recruiting | Las Vegas | Nevada | 89106 | United States |
| Clinical Research Integrity (CRI) Lifetree, LLC | Recruiting | Marlton | New Jersey | 08053 | United States |
| Premier Health Research | Recruiting | Sparta | New Jersey | 07871 | United States |
| Coastal Research Institute | Recruiting | Fayetteville | North Carolina | 28304 | United States |
| Akron Gastro Research | Recruiting | Akron | Ohio | 44333 | United States |
| Digestive Specialists | Recruiting | Dayton | Ohio | 45414 | United States |
| DSI Research | Recruiting | Springboro | Ohio | 45066 | United States |
| Clinical Research Institute of Ohio (CRIOH), LLC | Recruiting | Westlake | Ohio | 44145 | United States |
| Columbia Gastroenterology Associates, Llc | Recruiting | Columbia | South Carolina | 29204 | United States |
| Pinnacle Clinical Research | Recruiting | Austin | Texas | 78757 | United States |
| Bellaire Clinical Research | Recruiting | Bellaire | Texas | 77401 | United States |
| South Texas Research Institute (STRI) - Brownsville | Recruiting | Brownsville | Texas | 78520 | United States |
| Pinnacle Clinical Research | Recruiting | Corpus Christi | Texas | 78404 | United States |
| South Texas Research Institute (STRI) | Recruiting | Edinburg | Texas | 78539 | United States |
| Dallas Research Institute, LLC | Recruiting | Farmers Branch | Texas | 75234 | United States |
| Care United Research | Recruiting | Forney | Texas | 75126 | United States |
| Evidentis Clinical Research | Recruiting | Fort Worth | Texas | 76104 | United States |
| Pinnacle Clinical Research - Georgetown | Recruiting | Georgetown | Texas | 78626 | United States |
| Houston Research Institute - Medical Center | Recruiting | Houston | Texas | 770004 | United States |
| Houston Research Institute | Recruiting | Houston | Texas | 77079 | United States |
| Houston Research Institute - Pasadena | Recruiting | Pasadena | Texas | 77505 | United States |
| Quality Research, Inc. | Recruiting | San Antonio | Texas | 78209 | United States |
| Pinnacle Clinical Research - South San Antonio | Recruiting | San Antonio | Texas | 78222 | United States |
| Pinnacle Clinical Research | Recruiting | San Antonio | Texas | 78229 | United States |
| Sugarland Medical Associates (Sma) | Recruiting | Sugar Land | Texas | 77478 | United States |
| Digestive Research of Central Texas | Recruiting | Waco | Texas | 76712 | United States |
| Digestive Health Research of North Texas, LLC | Recruiting | Wichita Falls | Texas | 76301 | United States |
| GI Select Health Research | Recruiting | Richmond | Virginia | 23236 | United States |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005234 | Fatty Liver |
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