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RECRUITING

NCT07288138

PHASE2

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)

Sponsor: Eccogene

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-12-15

Completion Date

2027-09-29

Last Updated

2026-05-19

Healthy Volunteers

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Interventions

DRUG

Placebo

Placebo will be administered as matching oral capsules.

DRUG

ECC4703

ECC4703 will be administered as oral capsules.

DRUG

ECC0509

ECC0509 will be administered as oral capsules.

DRUG

ECC4703

ECC4703 will be administered as oral capsules.

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.

Locations (56)

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

Ark Clinical Research

Long Beach, California, United States

Knowledge Research Center

Orange, 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

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

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

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

Digestive Research of Central Texas

Waco, Texas, United States

Digestive Health Research of North Texas, LLC

Wichita Falls, Texas, United States

GI Select Health Research

Richmond, Virginia, United States

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)