Recruiting
Phase 2

ECC4703, ECC0509, Combination

Sponsor:

Eccogene

Code:

NCT07288138

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

ECC4703

ECC0509

ECC4703

Study Details

Brief 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.

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Study ID

NCT07288138

Start date

Dec 15, 2025

Status verified date

Sep, 2026

Completion date

Sep 29, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures.
2. 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.
3. Evidence of hepatic steatosis confirmed by FibroScan® LSM > 7 kPa and < 20 kPa and MRI-PDFF >8% at screening.
4. BMI >25 kg/m\^2 to <50 kg/m\^2 (non-Asian); BMI ≥23.0 to <50.0 kg/m\^2 (Asian).
5. ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period.
6. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\^2 (Chronic Kidney Disease Epidemiology Collaboration, \[CKD-EPI\]).
7. Stable body weight (no >5% change) for at least 6 months prior to screening.
8. Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).
9. In the opinion of the investigator, able to participate safely and complete required MRI/biomarker assessments.

Exclusion Criteria:

1. 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.
2. 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).
3. ALT and/or AST >5× Upper Limit of Normal (ULN) or ALP >2×ULN at screening.
4. Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders.
5. Type 1 diabetes, HbA1c >9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.
6. 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.
7. Significant alcohol use within 1 year prior to screening.
8. Recent cardiovascular events, including myocardial infraction (MI), stroke, unstable angina, heart failure (New York heart association \[NYHA III-IV\]), or uncontrolled arrhythmia.
9. Current or recent serious psychiatric illness, including psychosis, active suicidal ideation, or suicide attempt within 5 years.
10. Pregnancy, breastfeeding, or conditions that increase risk or interfere with study procedures, including MRI contraindications or other investigator-determined safety concerns.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

experimental: ECC4703 Low Dose

experimental: ECC4703 High Dose

experimental: ECC4703 High Dose + ECC0509 High Dose

experimental: ECC0509 Low Dose

experimental: ECC0509 High Dose

Interventions

Placebo

Placebo will be administered as matching oral capsules.

ECC4703

ECC4703 will be administered as oral capsules.

ECC0509

ECC0509 will be administered as oral capsules.

ECC4703

ECC4703 will be administered as oral capsules.

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 ]

Central Contacts and Locations

Central contacts

Eccogene Clinical Trials

86-21-61053022contact@eccogene.com

Locations

Arizona Liver Health

Recruiting

Chandler, Arizona, United States, 85224

Arizona Liver Health - Peoria

Recruiting

Peoria, Arizona, United States, 85381

Adobe Clinical Research, LLC

Recruiting

Tucson, Arizona, United States, 85712

Arizona Liver Health - Tucson

Recruiting

Tucson, Arizona, United States, 85712

Arkansas Gastroenterology, P.A

Recruiting

Little Rock, Arkansas, United States, 71913

ARcare Center for Clinical Research

Recruiting

Little Rock, Arkansas, United States, 77205

Om Research

Recruiting

Apple Valley, California, United States, 92307

ARK Clinical Research - Fountain Valley

Recruiting

Fountain Valley, California, United States, 92708

UCSD Medical Center

Recruiting

La Jolla, California, United States, 92037

Om Research

Recruiting

Lancaster, California, United States, 93534

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Knowledge Research Center

Recruiting

Orange, California, United States, 92868

Om Research

Recruiting

Victorville, California, United States, 92395

Synergy Healthcare

Recruiting

Bradenton, Florida, United States, 33511

Synergy Healthcare

Recruiting

Bradenton, Florida, United States, 34209

Health Awareness, Inc.

Recruiting

Jupiter, Florida, United States, 33458

Evolution Clinical Trials

Recruiting

Miami, Florida, United States, 33122

Floridian Clinical Research, LLC

Recruiting

Miami Lakes, Florida, United States, 33016

Ocala GI Research

Recruiting

Ocala, Florida, United States, 34471

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

ClinCloud, LLC

Recruiting

Viera, Florida, United States, 32940

Metabolic Research Institute

Recruiting

West Palm Beach, Florida, United States, 33401

CenExel - iResearch

Recruiting

Decatur, Georgia, United States, 30030

Gastrointestinal Specialists of Georgia, PC

Recruiting

Marietta, Georgia, United States, 30060

Digestive Research Alliance of Michiana

Recruiting

South Bend, Indiana, United States, 46635

Tandem Clinical Research

Recruiting

Covington, Louisiana, United States, 70433

Tandem Clinical Research

Recruiting

Houma, Louisiana, United States, 70360

Tandem Clinical Research GI, LLC

Recruiting

Marrero, Louisiana, United States, 70072

Tandem Clinical Research

Recruiting

Metairie, Louisiana, United States, 70006

Delta Research Partners

Recruiting

Monroe, Louisiana, United States, 71201

Louisiana Research Center, LLC

Recruiting

Shreveport, Louisiana, United States, 71105

Delta Research Partners, LLC

Recruiting

West Monroe, Louisiana, United States, 71291

Mid-Atlantic GI Research

Recruiting

Greenbelt, Maryland, United States, 20770

Gastrointestinal Associates

Recruiting

Columbia, Missouri, United States, 65201

Gateway GI Research, LLC

Recruiting

St Louis, Missouri, United States, 63141

Jubilee Clinical Research, Inc

Recruiting

Las Vegas, Nevada, United States, 89106

Clinical Research Integrity (CRI) Lifetree, LLC

Recruiting

Marlton, New Jersey, United States, 08053

Premier Health Research

Recruiting

Sparta, New Jersey, United States, 07871

Coastal Research Institute

Recruiting

Fayetteville, North Carolina, United States, 28304

Akron Gastro Research

Recruiting

Akron, Ohio, United States, 44333

Digestive Specialists

Recruiting

Dayton, Ohio, United States, 45414

DSI Research

Recruiting

Springboro, Ohio, United States, 45066

Clinical Research Institute of Ohio (CRIOH), LLC

Recruiting

Westlake, Ohio, United States, 44145

Columbia Gastroenterology Associates, Llc

Recruiting

Columbia, South Carolina, United States, 29204

Pinnacle Clinical Research

Recruiting

Austin, Texas, United States, 78757

Bellaire Clinical Research

Recruiting

Bellaire, Texas, United States, 77401

South Texas Research Institute (STRI) - Brownsville

Recruiting

Brownsville, Texas, United States, 78520

Pinnacle Clinical Research

Recruiting

Corpus Christi, Texas, United States, 78404

South Texas Research Institute (STRI)

Recruiting

Edinburg, Texas, United States, 78539

Dallas Research Institute, LLC

Recruiting

Farmers Branch, Texas, United States, 75234

Care United Research

Recruiting

Forney, Texas, United States, 75126

Evidentis Clinical Research

Recruiting

Fort Worth, Texas, United States, 76104

Pinnacle Clinical Research - Georgetown

Recruiting

Georgetown, Texas, United States, 78626

Houston Research Institute - Medical Center

Recruiting

Houston, Texas, United States, 770004

Houston Research Institute

Recruiting

Houston, Texas, United States, 77079

Houston Research Institute - Pasadena

Recruiting

Pasadena, Texas, United States, 77505

Quality Research, Inc.

Recruiting

San Antonio, Texas, United States, 78209

Pinnacle Clinical Research - South San Antonio

Recruiting

San Antonio, Texas, United States, 78222

Pinnacle Clinical Research

Recruiting

San Antonio, Texas, United States, 78229

Sugarland Medical Associates (Sma)

Recruiting

Sugar Land, Texas, United States, 77478

Digestive Research of Central Texas

Recruiting

Waco, Texas, United States, 76712

Digestive Health Research of North Texas, LLC

Recruiting

Wichita Falls, Texas, United States, 76301

GI Alliance Richmond

Recruiting

Richmond, Virginia, United States, 23229

GI Select Health Research

Recruiting

Richmond, Virginia, United States, 23236

More Information

Sponsor

Eccogene

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Liver Disease
  • Nonalcoholic Steatohepatitis
  • ECC0509
  • ECC4703

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eccogene on 2026-09-03.