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NCT07288138PHASE2Recruiting

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)

Eccogene

Start Date

12/15/2025

Completion Date

9/29/2027

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Placebo

DRUG

ECC4703

DRUG

ECC0509

DRUG

ECC4703

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Conditions

Metabolic Dysfunction-associated Steatohepatitis

Locations

Arizona Liver Health

Chandler, Arizona 85224

United States

Arizona Liver Health - Peoria

Peoria, Arizona 85381

United States

Adobe Clinical Research, LLC

Tucson, Arizona 85712

United States

Arizona Liver Health - Tucson

Tucson, Arizona 85712

United States

Arkansas Gastroenterology, P.A

Little Rock, Arkansas 71913

United States

ARcare Center for Clinical Research

Little Rock, Arkansas 77205

United States

Om Research

Apple Valley, California 92307

United States

ARK Clinical Research - Fountain Valley

Fountain Valley, California 92708

United States

Om Research

Lancaster, California 93534

United States

Ark Clinical Research

Long Beach, California 90815

United States

Knowledge Research Center

Orange, California 92868

United States

Om Research

Victorville, California 92395

United States

Synergy Healthcare

Bradenton, Florida 33511

United States

Synergy Healthcare

Bradenton, Florida 34209

United States

Health Awareness, Inc.

Jupiter, Florida 33458

United States

Evolution Clinical Trials

Miami, Florida 33122

United States

Floridian Clinical Research, LLC

Miami Lakes, Florida 33016

United States

Ocala GI Research

Ocala, Florida 34471

United States

Progressive Medical Research

Port Orange, Florida 32127

United States

ClinCloud, LLC

Viera, Florida 32940

United States

Metabolic Research Institute

West Palm Beach, Florida 33401

United States

CenExel - iResearch

Decatur, Georgia 30030

United States

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia 30060

United States

Digestive Research Alliance of Michiana

South Bend, Indiana 46635

United States

Tandem Clinical Research

Covington, Louisiana 70433

United States

Tandem Clinical Research

Houma, Louisiana 70360

United States

Tandem Clinical Research GI, LLC

Marrero, Louisiana 70072

United States

Tandem Clinical Research

Metairie, Louisiana 70006

United States

Delta Research Partners

Monroe, Louisiana 71201

United States

Louisiana Research Center, LLC

Shreveport, Louisiana 71105

United States

Delta Research Partners, LLC

West Monroe, Louisiana 71291

United States

Mid-Atlantic GI Research

Greenbelt, Maryland 20770

United States

Gastrointestinal Associates

Columbia, Missouri 65201

United States

Gateway GI Research, LLC

St Louis, Missouri 63141

United States

Jubilee Clinical Research, Inc

Las Vegas, Nevada 89106

United States

Clinical Research Integrity (CRI) Lifetree, LLC

Marlton, New Jersey 08053

United States

Premier Health Research

Sparta, New Jersey 07871

United States

Coastal Research Institute

Fayetteville, North Carolina 28304

United States

Akron Gastro Research

Akron, Ohio 44333

United States

Digestive Specialists

Dayton, Ohio 45414

United States

DSI Research

Springboro, Ohio 45066

United States

Clinical Research Institute of Ohio (CRIOH), LLC

Westlake, Ohio 44145

United States

Columbia Gastroenterology Associates, Llc

Columbia, South Carolina 29204

United States

Pinnacle Clinical Research

Austin, Texas 78757

United States

Bellaire Clinical Research

Bellaire, Texas 77401

United States

South Texas Research Institute (STRI) - Brownsville

Brownsville, Texas 78520

United States

Pinnacle Clinical Research

Corpus Christi, Texas 78404

United States

South Texas Research Institute (STRI)

Edinburg, Texas 78539

United States

Dallas Research Institute, LLC

Farmers Branch, Texas 75234

United States

Care United Research

Forney, Texas 75126

United States

Evidentis Clinical Research

Fort Worth, Texas 76104

United States

Pinnacle Clinical Research - Georgetown

Georgetown, Texas 78626

United States

Houston Research Institute - Medical Center

Houston, Texas 770004

United States

Houston Research Institute

Houston, Texas 77079

United States

Houston Research Institute - Pasadena

Pasadena, Texas 77505

United States

Quality Research, Inc.

San Antonio, Texas 78209

United States

Pinnacle Clinical Research - South San Antonio

San Antonio, Texas 78222

United States

Pinnacle Clinical Research

San Antonio, Texas 78229

United States

Sugarland Medical Associates (Sma)

Sugar Land, Texas 77478

United States

Digestive Research of Central Texas

Waco, Texas 76712

United States

Digestive Health Research of North Texas, LLC

Wichita Falls, Texas 76301

United States

GI Select Health Research

Richmond, Virginia 23236

United States