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Recruiting Phase 2 NCT07288138

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)

Phase 2 – studying effectiveness and dosage
Conditions: Metabolic Dysfunction-associated Steatohepatitis

Sponsor: Eccogene

trial.available_in: БГ
Overview
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 participate
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
Placebo
DRUG
ECC4703
DRUG
ECC0509
DRUG
ECC4703
DRUG
Locations 53
United States (53)
Akron Gastro Research
Akron , Ohio
Pinnacle Clinical Research
Austin , Texas
Bellaire Clinical Research
Bellaire , Texas
Synergy Healthcare
Bradenton , Florida
Synergy Healthcare
Bradenton , Florida
South Texas Research Institute (STRI) - Brownsville
Brownsville , Texas
Arizona Liver Health
Chandler , Arizona
Gastrointestinal Associates
Columbia , Missouri
Columbia Gastroenterology Associates, Llc
Columbia , South Carolina
Pinnacle Clinical Research
Corpus Christi , Texas
Tandem Clinical Research
Covington , Louisiana
Digestive Specialists
Dayton , Ohio
CenExel - iResearch
Decatur , Georgia
South Texas Research Institute (STRI)
Edinburg , Texas
Dallas Research Institute, LLC
Farmers Branch , Texas
Care United Research
Forney , Texas
ARK Clinical Research - Fountain Valley
Fountain Valley , California
Pinnacle Clinical Research - Georgetown
Georgetown , Texas
Mid-Atlantic GI Research
Greenbelt , Maryland
Tandem Clinical Research
Houma , Louisiana
Houston Research Institute - Medical Center
Houston , Texas
Houston Research Institute
Houston , Texas
Health Awareness, Inc.
Jupiter , Florida
Arkansas Gastroenterology, P.A
Little Rock , Arkansas
ARcare Center for Clinical Research
Little Rock , Arkansas
Ark Clinical Research
Long Beach , California
Gastrointestinal Specialists of Georgia, PC
Marietta , Georgia
Tandem Clinical Research GI, LLC
Marrero , Louisiana
Tandem Clinical Research
Metairie , Louisiana
Evolution Clinical Trials
Miami , Florida
Floridian Clinical Research, LLC
Miami Lakes , Florida
Delta Research Partners
Monroe , Louisiana
Ocala GI Research
Ocala , Florida
Knowledge Research Center
Orange , California
Houston Research Institute - Pasadena
Pasadena , Texas
Arizona Liver Health - Peoria
Peoria , Arizona
Progressive Medical Research
Port Orange , Florida
GI Select Health Research
Richmond , Virginia
Quality Research, Inc.
San Antonio , Texas
Pinnacle Clinical Research - South San Antonio
San Antonio , Texas
Pinnacle Clinical Research
San Antonio , Texas
Louisiana Research Center, LLC
Shreveport , Louisiana
Digestive Research Alliance of Michiana
South Bend , Indiana
Premier Health Research
Sparta , New Jersey
DSI Research
Springboro , Ohio
Gateway GI Research, LLC
St Louis , Missouri
Sugarland Medical Associates (Sma)
Sugar Land , Texas
Adobe Clinical Research, LLC
Tucson , Arizona
Arizona Liver Health - Tucson
Tucson , Arizona
ClinCloud, LLC
Viera , Florida
Digestive Research of Central Texas
Waco , Texas
Delta Research Partners, LLC
West Monroe , Louisiana
Digestive Health Research of North Texas, LLC
Wichita Falls , Texas
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
15.12.2025
Completion date
29.09.2027
Registry ID
NCT07288138
Source
clinicaltrials.gov
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