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)
Recruiting · NCT07288138 · Interventional (participants receive a specific treatment) · Lead sponsor: Eccogene
View the official record on ClinicalTrials.gov →Interventions studied
ECC0509ECC4703Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
- 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.
Where it is running
60 locations listed across 16 US states.
- Arizona Liver Health - Chandler, Arizona, United States
- Arizona Liver Health - Peoria - Peoria, Arizona, United States
- Adobe Clinical Research, LLC - Tucson, Arizona, United States
- Arizona Liver Health - Tucson - Tucson, Arizona, United States
- Arkansas Gastroenterology, P.A - Little Rock, Arkansas, United States
- ARcare Center for Clinical Research - Little Rock, Arkansas, United States
- Om Research - Apple Valley, California, United States
- ARK Clinical Research - Fountain Valley - Fountain Valley, California, United States
- UCSD Medical Center - La Jolla, California, United States
- Om Research - Lancaster, California, United States
- Ark Clinical Research - Long Beach, California, United States
- Knowledge Research Center - Orange, California, United States
- Om Research - Victorville, California, United States
- Synergy Healthcare - Bradenton, Florida, United States
- Synergy Healthcare - Bradenton, Florida, United States
- Health Awareness, Inc. - Jupiter, Florida, United States
- Evolution Clinical Trials - Miami, Florida, United States
- Floridian Clinical Research, LLC - Miami Lakes, Florida, United States
- Ocala GI Research - Ocala, Florida, United States
- Progressive Medical Research - Port Orange, Florida, United States
- ClinCloud, LLC - Viera, Florida, United States
- Metabolic Research Institute - West Palm Beach, Florida, United States
- CenExel - iResearch - Decatur, Georgia, United States
- Gastrointestinal Specialists of Georgia, PC - Marietta, Georgia, United States
- Digestive Research Alliance of Michiana - South Bend, Indiana, United States
- Tandem Clinical Research - Covington, Louisiana, United States
- Tandem Clinical Research - Houma, Louisiana, United States
- Tandem Clinical Research GI, LLC - Marrero, Louisiana, United States
- Tandem Clinical Research - Metairie, Louisiana, United States
- Delta Research Partners - Monroe, Louisiana, United States
- Louisiana Research Center, LLC - Shreveport, Louisiana, United States
- Delta Research Partners, LLC - West Monroe, Louisiana, United States
- Mid-Atlantic GI Research - Greenbelt, Maryland, United States
- Gastrointestinal Associates - Columbia, Missouri, United States
- Gateway GI Research, LLC - St Louis, Missouri, United States
- Jubilee Clinical Research, Inc - Las Vegas, Nevada, United States
- Clinical Research Integrity (CRI) Lifetree, LLC - Marlton, New Jersey, United States
- Premier Health Research - Sparta, New Jersey, United States
- Coastal Research Institute - Fayetteville, North Carolina, United States
- Akron Gastro Research - Akron, Ohio, United States
- Digestive Specialists - Dayton, Ohio, United States
- DSI Research - Springboro, Ohio, United States
- Clinical Research Institute of Ohio (CRIOH), LLC - Westlake, Ohio, United States
- Columbia Gastroenterology Associates, Llc - Columbia, South Carolina, United States
- Pinnacle Clinical Research - Austin, Texas, United States
- Bellaire Clinical Research - Bellaire, Texas, United States
- South Texas Research Institute (STRI) - Brownsville - Brownsville, Texas, United States
- Pinnacle Clinical Research - Corpus Christi, Texas, United States
- South Texas Research Institute (STRI) - Edinburg, Texas, United States
- Dallas Research Institute, LLC - Farmers Branch, Texas, United States
- Care United Research - Forney, Texas, United States
- Evidentis Clinical Research - Fort Worth, Texas, United States
- Pinnacle Clinical Research - Georgetown - Georgetown, Texas, United States
- Houston Research Institute - Medical Center - Houston, Texas, United States
- Houston Research Institute - Houston, Texas, United States
- Houston Research Institute - Pasadena - Pasadena, Texas, United States
- Quality Research, Inc. - San Antonio, Texas, United States
- Pinnacle Clinical Research - South San Antonio - San Antonio, Texas, United States
- Pinnacle Clinical Research - San Antonio, Texas, United States
- Sugarland Medical Associates (Sma) - Sugar Land, Texas, United States
Showing 60 of 64 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →