Two experimental drugs, alone and together, for fatty liver disease with inflammation (MASH)
Tests ECC4703 and ECC0509, alone and combined, in adults with presumed MASH.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Akron, Apple Valley, Austin, Bellaire, Bradenton, Brownsville, Chandler, Columbia, Cordova, Corpus Christi, Covington, Dayton, Decatur, Edinburg, Farmers Branch, Fayetteville, Forney, Fort Worth, Fountain Valley, Garland, Georgetown, Glenview, Greenbelt, Gurnee, Houma, Houston, Jupiter, La Jolla, Lancaster, Las Vegas, Little Rock, Long Beach, Marietta, Marlton, Marrero, Metairie, Miami, Miami Lakes, Monroe, Ocala, Orange, Pasadena, Peoria, Port Orange, Richmond, San Antonio, Shreveport, South Bend, Sparta, Springboro, St Louis, Sugar Land, Tucson, Victorville, Viera, Waco, Webster, West Monroe, West Palm Beach, Westlake, and Wichita Falls, United StatesSee the 69 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07288138, who can take part
Where in United States
- Akron Gastro ResearchAkron, United StatesTaking people
- Om ResearchApple Valley, United StatesTaking people
- Pinnacle Clinical ResearchAustin, United StatesTaking people
- Bellaire Clinical ResearchBellaire, United StatesTaking people
- Synergy HealthcareBradenton, United StatesTaking people
- South Texas Research Institute (STRI) - BrownsvilleBrownsville, United StatesTaking people
- Arizona Liver HealthChandler, United StatesTaking people
- Columbia Gastroenterology Associates, LlcColumbia, United StatesTaking people
- Gastrointestinal AssociatesColumbia, United StatesTaking people
- Gastro OneCordova, United StatesTaking people
- Pinnacle Clinical ResearchCorpus Christi, United StatesTaking people
- Tandem Clinical ResearchCovington, United StatesTaking people
- Dayton Gastroenterology - EnglewoodDayton, United StatesTaking people
- Digestive SpecialistsDayton, United StatesTaking people
- CenExel iResearchDecatur, United StatesTaking people
- South Texas Research Institute (STRI)Edinburg, United StatesTaking people
- Dallas Research Institute, LLCFarmers Branch, United StatesTaking people
- Coastal Research InstituteFayetteville, United StatesTaking people
- Care United ResearchForney, United StatesTaking people
- Evidentis Clinical ResearchFort Worth, United StatesTaking people
- Ark Clinical Research, Fountain ValleyFountain Valley, United StatesTaking people
- GI Alliance Digestive Health Associates of Texas - GarlandGarland, United StatesTaking people
- Pinnacle Clinical Research - GeorgetownGeorgetown, United StatesTaking people
- GI Alliance GlenviewGlenview, United StatesTaking people
- Mid-Atlantic GI ResearchGreenbelt, United StatesTaking people
- GI Alliance GurneeGurnee, United StatesTaking people
- Tandem Clinical ResearchHouma, United StatesTaking people
- Houston Research InstituteHouston, United StatesTaking people
- Houston Research Institute - Medical CenterHouston, United StatesTaking people
- Health Awareness, IncJupiter, United StatesTaking people
- UCSD Medical CenterLa Jolla, United StatesTaking people
- Om ResearchLancaster, United StatesTaking people
- Jubilee Clinical Research, Inc.Las Vegas, United StatesTaking people
- ARcare Center for Clinical ResearchLittle Rock, United StatesTaking people
- Arkansas Gastroenterology, P.ALittle Rock, United StatesTaking people
- Ark Clinical ResearchLong Beach, United StatesTaking people
- Gastrointestinal Specialists of Georgia, PCMarietta, United StatesTaking people
- Clinical Research Integrity (CRI) Lifetree, LLCMarlton, United StatesTaking people
- Tandem Clinical Research GI, LLCMarrero, United StatesTaking people
- Tandem Clinical ResearchMetairie, United StatesTaking people
- Evolution Clinical TrialsMiami, United StatesTaking people
- Floridian Clinical Research, LLCMiami Lakes, United StatesTaking people
- Delta Research PartnersMonroe, United StatesTaking people
- Ocala GI ResearchOcala, United StatesTaking people
- Knowledge Research CenterOrange, United StatesTaking people
- Houston Research Institute - PasadenaPasadena, United StatesTaking people
- Arizona Liver Health - PeoriaPeoria, United StatesTaking people
- Progressive Medical ResearchPort Orange, United StatesTaking people
- GI Select Health ResearchRichmond, United StatesTaking people
- GI Alliance RichmondRichmond, United StatesNo longer taking part
- Pinnacle Clinical ResearchSan Antonio, United StatesTaking people
- Pinnacle Clinical Research - South San AntonioSan Antonio, United StatesTaking people
- Quality Research IncSan Antonio, United StatesTaking people
- Louisiana Research Center, LLCShreveport, United StatesTaking people
- Digestive Research Alliance of MichianaSouth Bend, United StatesNo longer taking part
- Premier Health ResearchSparta, United StatesTaking people
- DSI ResearchSpringboro, United StatesTaking people
- Gateway GI Research, LLCSt Louis, United StatesTaking people
- Sugarland Medical Associates (Sma)Sugar Land, United StatesTaking people
- Adobe Clinical Research LLCTucson, United StatesTaking people
- Arizona Liver Health - TucsonTucson, United StatesTaking people
- Om ResearchVictorville, United StatesTaking people
- ClinCloud, LLCViera, United StatesTaking people
- Digestive Research of Central TexasWaco, United StatesNo longer taking part
- GI Alliance WebsterWebster, United StatesTaking people
- Delta Research Partners, LLCWest Monroe, United StatesTaking people
- Metabolic Research InstituteWest Palm Beach, United StatesTaking people
- Clinical Research Institute of Ohio (CRIOH), LLCWestlake, United StatesTaking people
- Digestive Health Research of North Texas, LLCWichita Falls, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eccogene
- Trial code
- NCT07288138
- Record updated
- 9 November 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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]); 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.
Exclusion: 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; Significant alcohol use within 1 year prior to screening; 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); Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders; 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; ALT and/or AST >5× Upper Limit of Normal (ULN) or ALP >2×ULN at screening; Type 1 diabetes, HbA1c >9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.