Metabolic Dysfunction-associated SteatohepatitisPhase 2NCT07288138
A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Phase 2 study testing ECC4703 and ECC0509 in people with Metabolic Dysfunction-associated Steatohepatitis, run by Eccogene at 68 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-associated Steatohepatitis
- What is being tested?
- ECC4703 and ECC0509
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 68 sitesUnited States
- Study dates
- 15 Dec 2025to 29 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures.
- Diagnosis of presumed MASH based on: liver biopsy within 180 days prior to screening showing an NAFLD activity score (NAS) of ≥3 and a fibrosis score (F) of F1-3 OR FibroScan® CAP >280 dB/m at screening with presence of metabolic risk factors.
- Evidence of hepatic steatosis confirmed by FibroScan® LSM > 7 kPa and < 20 kPa and MRI-PDFF >8% at screening.
- BMI >25 kg/m^2 to <50 kg/m^2 (non-Asian); BMI ≥23.0 to <50.0 kg/m^2 (Asian).
- ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period.
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m^2 (Chronic Kidney Disease Epidemiology Collaboration, [CKD-EPI]).
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- Stable body weight (no >5% change) for at least 6 months prior to screening.
- Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).
- In the opinion of the investigator, able to participate safely and complete required MRI/biomarker assessments.
Who cannot join
- Chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH, including alcoholic liver disease, autoimmune hepatitis, cholestatic disease, genetic liver diseases, or drug-induced liver injury.
- Presence of cirrhosis on liver histology according to the assessment of the central reader, and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension (e.g, nodular liver contour; portosystemic collaterals, ascites, splenomegaly; known presence or history of esophageal varices; and/or elastography evidence consistent with cirrhosis).
- ALT and/or AST >5× Upper Limit of Normal (ULN) or ALP >2×ULN at screening.
- Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders.
- Type 1 diabetes, HbA1c >9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.
- Use of medications that affect liver fat or fibrosis (e.g., Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) not on a stable dose, pioglitazone, obeticholic acid, high-dose vitamin E, hepatotoxic drugs) within protocol-specified washout periods.
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- Significant alcohol use within 1 year prior to screening.
- Recent cardiovascular events, including myocardial infraction (MI), stroke, unstable angina, heart failure (New York heart association [NYHA III-IV]), or uncontrolled arrhythmia.
- Current or recent serious psychiatric illness, including psychosis, active suicidal ideation, or suicide attempt within 5 years.
- Pregnancy, breastfeeding, or conditions that increase risk or interfere with study procedures, including MRI contraindications or other investigator-determined safety concerns.
Trial locations and contacts
68 sites in 1 country. Contact the study team or a site near you to ask about taking part.
68 sites in 1 country
United States68 sites, 67 recruiting
- Recruiting
Akron Gastro Research
Akron, Ohio, 44333
- Recruiting
Om Research
Apple Valley, California, 92307
- Recruiting
Pinnacle Clinical Research
Austin, Texas, 78757
- Recruiting
Bellaire Clinical Research
Bellaire, Texas, 77401
- Recruiting
Synergy Healthcare
Bradenton, Florida, 33511
- Recruiting
Synergy Healthcare
Bradenton, Florida, 34209
- Recruiting
South Texas Research Institute (STRI) - Brownsville
Brownsville, Texas, 78520
- Recruiting
Arizona Liver Health
Chandler, Arizona, 85224
- Recruiting
Gastrointestinal Associates
Columbia, Missouri, 65201
- Recruiting
Columbia Gastroenterology Associates, Llc
Columbia, South Carolina, 29204
- Recruiting
Pinnacle Clinical Research
Corpus Christi, Texas, 78404
- Recruiting
Tandem Clinical Research
Covington, Louisiana, 70433
- Recruiting
Digestive Specialists
Dayton, Ohio, 45414
- Recruiting
CenExel - iResearch
Decatur, Georgia, 30030
- Recruiting
South Texas Research Institute (STRI)
Edinburg, Texas, 78539
- Recruiting
Dallas Research Institute, LLC
Farmers Branch, Texas, 75234
- Recruiting
Coastal Research Institute
Fayetteville, North Carolina, 28304
- Recruiting
Care United Research
Forney, Texas, 75126
- Recruiting
Evidentis Clinical Research
Fort Worth, Texas, 76104
- Recruiting
ARK Clinical Research - Fountain Valley
Fountain Valley, California, 92708
- Recruiting
GI Alliance Digestive Health Associates of Texas - Garland
Garland, Texas, 75044
- Recruiting
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, 78626
- Recruiting
GI Alliance Glenview
Glenview, Illinois, 60026
- Recruiting
Mid-Atlantic GI Research
Greenbelt, Maryland, 20770
- Recruiting
GI Alliance Gurnee
Gurnee, Illinois, 60031
- Recruiting
Tandem Clinical Research
Houma, Louisiana, 70360
- Recruiting
Houston Research Institute - Medical Center
Houston, Texas, 770004
- Recruiting
Houston Research Institute
Houston, Texas, 77079
- Recruiting
Health Awareness, Inc.
Jupiter, Florida, 33458
- Recruiting
UCSD Medical Center
La Jolla, California, 92037
- Recruiting
Om Research
Lancaster, California, 93534
- Recruiting
Jubilee Clinical Research, Inc
Las Vegas, Nevada, 89106
- Recruiting
Arkansas Gastroenterology, P.A
Little Rock, Arkansas, 71913
- Recruiting
ARcare Center for Clinical Research
Little Rock, Arkansas, 77205
- Recruiting
Ark Clinical Research
Long Beach, California, 90815
- Recruiting
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
- Recruiting
Clinical Research Integrity (CRI) Lifetree, LLC
Marlton, New Jersey, 08053
- Recruiting
Tandem Clinical Research GI, LLC
Marrero, Louisiana, 70072
- Recruiting
Tandem Clinical Research
Metairie, Louisiana, 70006
- Recruiting
Evolution Clinical Trials
Miami, Florida, 33122
- Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
- Recruiting
Delta Research Partners
Monroe, Louisiana, 71201
- Recruiting
Ocala GI Research
Ocala, Florida, 34471
- Recruiting
Knowledge Research Center
Orange, California, 92868
- Recruiting
Houston Research Institute - Pasadena
Pasadena, Texas, 77505
- Recruiting
Arizona Liver Health - Peoria
Peoria, Arizona, 85381
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
- Recruiting
GI Alliance Richmond
Richmond, Virginia, 23229
- Recruiting
GI Select Health Research
Richmond, Virginia, 23236
- Recruiting
Quality Research, Inc.
San Antonio, Texas, 78209
- Recruiting
Pinnacle Clinical Research - South San Antonio
San Antonio, Texas, 78222
- Recruiting
Pinnacle Clinical Research
San Antonio, Texas, 78229
- Recruiting
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
- Recruiting
Digestive Research Alliance of Michiana
South Bend, Indiana, 46635
- Recruiting
Premier Health Research
Sparta, New Jersey, 07871
- Recruiting
DSI Research
Springboro, Ohio, 45066
- Recruiting
Gateway GI Research, LLC
St Louis, Missouri, 63141
- Recruiting
Sugarland Medical Associates (Sma)
Sugar Land, Texas, 77478
- Recruiting
Adobe Clinical Research, LLC
Tucson, Arizona, 85712
- Recruiting
Arizona Liver Health - Tucson
Tucson, Arizona, 85712
- Recruiting
Om Research
Victorville, California, 92395
- Recruiting
ClinCloud, LLC
Viera, Florida, 32940
- Completed
Digestive Research of Central Texas
Waco, Texas, 76712
- Recruiting
GI Alliance Webster
Webster, Texas, 77598
- Recruiting
Delta Research Partners, LLC
West Monroe, Louisiana, 71291
- Recruiting
Metabolic Research Institute
West Palm Beach, Florida, 33401
- Recruiting
Clinical Research Institute of Ohio (CRIOH), LLC
Westlake, Ohio, 44145
- Recruiting
Digestive Health Research of North Texas, LLC
Wichita Falls, Texas, 76301
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a THRβ Agonist (ECC4703), an SSAO Inhibitor (ECC0509), and Their Combination in Adults With Presumed MASH
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.
- Being tested
- Placebo, ECC4703, ECC0509
- Keywords
- Liver Disease, Nonalcoholic Steatohepatitis, ECC0509, ECC4703
- Medical subject headings
- Liver Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be administered as matching oral capsules.
ECC4703Drug
ECC4703 will be administered as oral capsules.
ECC0509Drug
ECC0509 will be administered as oral capsules.
ECC4703Drug
ECC4703 will be administered as oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| ECC4703 Low Dose | Experimental | Not described Receives: Drug: ECC4703 |
| ECC4703 High Dose | Experimental | Not described Receives: Drug: ECC4703 |
| ECC4703 High Dose + ECC0509 High Dose | Experimental | Not described Receives: Drug: ECC0509; Drug: ECC4703 |
| ECC0509 Low Dose | Experimental | Not described Receives: Drug: ECC0509 |
| ECC0509 High Dose | Experimental | Not described Receives: Drug: ECC0509 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo
Measured: Baseline and Week 12
Secondary outcomes (35)
Absolute Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline to Week 12
Change from Baseline in Lipoprotein(a) (Lp[a]) Profiles
Measured: Baseline to Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline to Week 12
Change from Baseline in Fasting Plasma Glucose (FPG)
Measured: Baseline to Week 12
Change from Baseline in Fasting Insulin
Measured: Baseline to Week 12
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Profiles
Measured: Baseline to Week 12
Change from Baseline in Body Weight
Measured: Baseline to Week 12
Change from Baseline Body Mass Index (BMI)
Measured: Baseline to Week 12
Change from Baseline in Plasma Methylamine
Measured: Baseline to Week 12
Change from Baseline in Cytokeratin-18 (CK-18)
Measured: Baseline to Week 12
Change from Baseline in C-telopeptide of Type III Collagen (CTX-III)
Measured: Baseline to Week 12
Change from Baseline in N-terminal Pro-peptide of Type III Collagen (Pro-C3)
Measured: Baseline to Week 12
Change in Ratio of Pro-C3
Measured: Week 12
Change in Ratio of CTX-III
Measured: Week 12
Change from Baseline in Chronic Liver Disease Questionnaire (CLDQ)
Measured: Baseline and Week 12
Change from Baseline in Short-form Liver Disease Quality of Life (SF-LDQOL)
Measured: Baseline to Week 12
Plasma Concentration of ECC4703 and ECC0509
Measured: Day 1, Weeks 2, 4, 6, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Dec 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eccogene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eccogene Clinical Trials, Study director, Eccogene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288138
- Sponsor's protocol ID
- EC0010
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a THRβ Agonist (ECC4703), an SSAO Inhibitor (ECC0509), and Their Combination in Adults With Presumed MASH
- ClinicalTrials.gov ID
- NCT07288138
- Acronym / sponsor ID
- EC0010
- Keywords
- Liver Disease, Nonalcoholic Steatohepatitis, ECC0509, ECC4703
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- EccogeneIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| ECC4703 Low Dose | Experimental | Drug: ECC4703 |
| ECC4703 High Dose | Experimental | Drug: ECC4703 |
| ECC4703 High Dose + ECC0509 High Dose | Experimental | Drug: ECC0509, Drug: ECC4703 |
| ECC0509 Low Dose | Experimental | Drug: ECC0509 |
| ECC0509 High Dose | Experimental | Drug: ECC0509 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures.
- Diagnosis of presumed MASH based on: liver biopsy within 180 days prior to screening showing an NAFLD activity score (NAS) of ≥3 and a fibrosis score (F) of F1-3 OR FibroScan® CAP >280 dB/m at screening with presence of metabolic risk factors.
- Evidence of hepatic steatosis confirmed by FibroScan® LSM > 7 kPa and < 20 kPa and MRI-PDFF >8% at screening.
- BMI >25 kg/m^2 to <50 kg/m^2 (non-Asian); BMI ≥23.0 to <50.0 kg/m^2 (Asian).
- ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period.
Key exclusion criteria (10 listed)
- Chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH, including alcoholic liver disease, autoimmune hepatitis, cholestatic disease, genetic liver diseases, or drug-induced liver injury.
- Presence of cirrhosis on liver histology according to the assessment of the central reader, and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension (e.g, nodular liver contour; portosystemic collaterals, ascites, splenomegaly; known presence or history of esophageal varices; and/or elastography evidence consistent with cirrhosis).
- ALT and/or AST >5× Upper Limit of Normal (ULN) or ALP >2×ULN at screening.
- Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders.
- Type 1 diabetes, HbA1c >9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo will be administered as matching oral capsules. | Drug | Placebo |
| ECC4703ECC4703 will be administered as oral capsules. | Drug | ECC4703 Low Dose |
| ECC0509ECC0509 will be administered as oral capsules. | Drug | ECC0509 High Dose, ECC0509 Low Dose, ECC4703 High Dose + ECC0509 High Dose |
| ECC4703ECC4703 will be administered as oral capsules. | Drug | ECC4703 High Dose, ECC4703 High Dose + ECC0509 High Dose |
Primary outcome
Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo
Time frame: Baseline and Week 12
35 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eccogene Clinical Trials study director
Eccogene
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ECC4703 and ECC0509 in people with Metabolic Dysfunction-associated Steatohepatitis, run by Eccogene at 68 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eccogene Clinical Trials (86-21-61053022, contact@eccogene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.