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Clinical Trials in the USA / NCT07288138
Recruiting Phase 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)

NCT07288138 · tracked via the Priya Life Science USA tracker
Sponsor
Eccogene
Phase
Phase 2
Started
2025-12-15
Last updated
2026-09-09

Condition(s) studied

Metabolic Dysfunction-associated Steatohepatitis

Investigational drug(s) / intervention(s)

PlaceboECC4703ECC0509ECC4703

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
Arizona Liver Health Chandler Arizona Recruiting
Arizona Liver Health - Peoria Peoria Arizona Recruiting
Adobe Clinical Research, LLC Tucson Arizona Recruiting
Arizona Liver Health - Tucson Tucson Arizona Recruiting
Arkansas Gastroenterology, P.A Little Rock Arkansas Recruiting
ARcare Center for Clinical Research Little Rock Arkansas Recruiting
Om Research Apple Valley California Recruiting
ARK Clinical Research - Fountain Valley Fountain Valley California Recruiting
UCSD Medical Center La Jolla California Recruiting
Om Research Lancaster California Recruiting
Ark Clinical Research Long Beach California Recruiting
Knowledge Research Center Orange California Recruiting
Om Research Victorville California Recruiting
Synergy Healthcare Bradenton Florida Recruiting
Synergy Healthcare Bradenton Florida Recruiting
Health Awareness, Inc. Jupiter Florida Recruiting
Evolution Clinical Trials Miami Florida Recruiting
Floridian Clinical Research, LLC Miami Lakes Florida Recruiting
Ocala GI Research Ocala Florida Recruiting
Progressive Medical Research Port Orange Florida Recruiting
ClinCloud, LLC Viera Florida Recruiting
Metabolic Research Institute West Palm Beach Florida Recruiting
CenExel - iResearch Decatur Georgia Recruiting
Gastrointestinal Specialists of Georgia, PC Marietta Georgia Recruiting
Digestive Research Alliance of Michiana South Bend Indiana Recruiting
Tandem Clinical Research Covington Louisiana Recruiting
Tandem Clinical Research Houma Louisiana Recruiting
Tandem Clinical Research GI, LLC Marrero Louisiana Recruiting
Tandem Clinical Research Metairie Louisiana Recruiting
Delta Research Partners Monroe Louisiana Recruiting
Louisiana Research Center, LLC Shreveport Louisiana Recruiting
Delta Research Partners, LLC West Monroe Louisiana Recruiting
Mid-Atlantic GI Research Greenbelt Maryland Recruiting
Gastrointestinal Associates Columbia Missouri Recruiting
Gateway GI Research, LLC St Louis Missouri Recruiting
Jubilee Clinical Research, Inc Las Vegas Nevada Recruiting
Clinical Research Integrity (CRI) Lifetree, LLC Marlton New Jersey Recruiting
Premier Health Research Sparta New Jersey Recruiting
Coastal Research Institute Fayetteville North Carolina Recruiting
Akron Gastro Research Akron Ohio Recruiting

+ 24 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07288138 on ClinicalTrials.gov ↗ ← All trials in the USA