NCT07288138RecruitingPhase 2
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 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
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 15 Sept 2027
- Lead sponsor
- Eccogene
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07288138
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 160
- From 15 Dec 2025 to the primary completion date, 15 Sept 2027
- 67 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (67)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akron Gastro Research Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| Om Research Coordinator of this site? Confirm its status | Apple Valley | United States | Recruiting |
| Pinnacle Clinical Research Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Bellaire Clinical Research Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Synergy Healthcare Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| South Texas Research Institute (STRI) - Brownsville Coordinator of this site? Confirm its status | Brownsville | United States | Recruiting |
| Arizona Liver Health Coordinator of this site? Confirm its status | Chandler | United States | Recruiting |
| Gastrointestinal Associates Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Columbia Gastroenterology Associates, Llc Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| Pinnacle Clinical Research Coordinator of this site? Confirm its status | Corpus Christi | United States | Recruiting |
| Tandem Clinical Research Coordinator of this site? Confirm its status | Covington | United States | Recruiting |
| Digestive Specialists Coordinator of this site? Confirm its status | Dayton | United States | Recruiting |
| CenExel iResearch Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| South Texas Research Institute (STRI) Coordinator of this site? Confirm its status | Edinburg | United States | Recruiting |
| Dallas Research Institute, LLC Coordinator of this site? Confirm its status | Farmers Branch | United States | Recruiting |
| Coastal Research Institute Coordinator of this site? Confirm its status | Fayetteville | United States | Recruiting |
| Care United Research Coordinator of this site? Confirm its status | Forney | United States | Recruiting |
| Evidentis Clinical Research Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Ark Clinical Research, Fountain Valley Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| GI Alliance Digestive Health Associates of Texas - Garland Coordinator of this site? Confirm its status | Garland | United States | Recruiting |
| Pinnacle Clinical Research - Georgetown Coordinator of this site? Confirm its status | Georgetown | United States | Recruiting |
| GI Alliance Glenview Coordinator of this site? Confirm its status | Glenview | United States | Recruiting |
| Mid-Atlantic GI Research Coordinator of this site? Confirm its status | Greenbelt | United States | Recruiting |
| GI Alliance Gurnee Coordinator of this site? Confirm its status | Gurnee | United States | Recruiting |
| Tandem Clinical Research Coordinator of this site? Confirm its status | Houma | United States | Recruiting |
| Houston Research Institute - Medical Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Houston Research Institute Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Health Awareness, Inc Coordinator of this site? Confirm its status | Jupiter | United States | Recruiting |
| UCSD Medical Center Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Om Research Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| Jubilee Clinical Research, Inc. Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Arkansas Gastroenterology, P.A Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| ARcare Center for Clinical Research Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Ark Clinical Research Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Gastrointestinal Specialists of Georgia, PC Coordinator of this site? Confirm its status | Marietta | United States | Recruiting |
| Clinical Research Integrity (CRI) Lifetree, LLC Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| Tandem Clinical Research GI, LLC Coordinator of this site? Confirm its status | Marrero | United States | Recruiting |
| Tandem Clinical Research Coordinator of this site? Confirm its status | Metairie | United States | Recruiting |
| Evolution Clinical Trials Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Floridian Clinical Research, LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Delta Research Partners Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| Ocala GI Research Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| Knowledge Research Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Houston Research Institute - Pasadena Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| Arizona Liver Health - Peoria Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Recruiting |
| GI Alliance Richmond Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| GI Select Health Research Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Quality Research Inc Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Pinnacle Clinical Research - South San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Pinnacle Clinical Research Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Louisiana Research Center, LLC Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| Digestive Research Alliance of Michiana Coordinator of this site? Confirm its status | South Bend | United States | Recruiting |
| Premier Health Research Coordinator of this site? Confirm its status | Sparta | United States | Recruiting |
| DSI Research Coordinator of this site? Confirm its status | Springboro | United States | Recruiting |
| Gateway GI Research, LLC Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Sugarland Medical Associates (Sma) Coordinator of this site? Confirm its status | Sugar Land | United States | Recruiting |
| Adobe Clinical Research LLC Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Arizona Liver Health - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Om Research Coordinator of this site? Confirm its status | Victorville | United States | Recruiting |
| ClinCloud, LLC Coordinator of this site? Confirm its status | Viera | United States | Recruiting |
| Digestive Research of Central Texas Coordinator of this site? Confirm its status | Waco | United States | Completed |
| GI Alliance Webster Coordinator of this site? Confirm its status | Webster | United States | Recruiting |
| Clinical Research Institute of Ohio (CRIOH), LLC Coordinator of this site? Confirm its status | Westlake | United States | Recruiting |
| Delta Research Partners, LLC Coordinator of this site? Confirm its status | West Monroe | United States | Recruiting |
| Metabolic Research Institute Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
| Digestive Health Research of North Texas, LLC Coordinator of this site? Confirm its status | Wichita Falls | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.