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)

Purpose

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.

Condition

  • Metabolic Dysfunction-associated Steatohepatitis

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
  • Drug: Placebo
    Placebo will be administered as matching oral capsules.
Experimental
ECC4703 Low Dose
  • Drug: ECC4703
    ECC4703 will be administered as oral capsules.
Experimental
ECC4703 High Dose
  • Drug: ECC4703
    ECC4703 will be administered as oral capsules.
Experimental
ECC4703 High Dose + ECC0509 High Dose
  • Drug: ECC0509
    ECC0509 will be administered as oral capsules.
  • Drug: ECC4703
    ECC4703 will be administered as oral capsules.
Experimental
ECC0509 Low Dose
  • Drug: ECC0509
    ECC0509 will be administered as oral capsules.
Experimental
ECC0509 High Dose
  • Drug: ECC0509
    ECC0509 will be administered as oral capsules.

Recruiting Locations

Arizona Liver Health
Chandler, Arizona 85224

Arizona Liver Health - Peoria
Peoria, Arizona 85381

Adobe Clinical Research, LLC
Tucson, Arizona 85712

Arizona Liver Health - Tucson
Tucson, Arizona 85712

Arkansas Gastroenterology, P.A
Little Rock, Arkansas 71913

ARcare Center for Clinical Research
Little Rock, Arkansas 77205

ARK Clinical Research - Fountain Valley
Fountain Valley, California 92708

Ark Clinical Research
Long Beach, California 90815

Knowledge Research Center
Orange, California 92868

Synergy Healthcare
Bradenton, Florida 33511

Synergy Healthcare
Bradenton, Florida 34209

Health Awareness, Inc.
Jupiter, Florida 33458

Evolution Clinical Trials
Miami, Florida 33122

Floridian Clinical Research, LLC
Miami Lakes, Florida 33016

Ocala GI Research
Ocala, Florida 34471

Progressive Medical Research
Port Orange, Florida 32127

ClinCloud, LLC
Viera, Florida 32940

CenExel - iResearch
Decatur, Georgia 30030

Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia 30060

Digestive Research Alliance of Michiana
South Bend, Indiana 46635

Tandem Clinical Research
Covington, Louisiana 70433

Tandem Clinical Research
Houma, Louisiana 70360

Tandem Clinical Research GI, LLC
Marrero, Louisiana 70072

Tandem Clinical Research
Metairie, Louisiana 70006

Delta Research Partners
Monroe, Louisiana 71201

Louisiana Research Center, LLC
Shreveport, Louisiana 71105

Delta Research Partners, LLC
West Monroe, Louisiana 71291

Mid-Atlantic GI Research
Greenbelt, Maryland 20770

Gastrointestinal Associates
Columbia, Missouri 65201

Gateway GI Research, LLC
St Louis, Missouri 63141

Premier Health Research
Sparta, New Jersey 07871

Akron Gastro Research
Akron, Ohio 44333

Digestive Specialists
Dayton, Ohio 45414

DSI Research
Springboro, Ohio 45066

Columbia Gastroenterology Associates, Llc
Columbia, South Carolina 29204

Pinnacle Clinical Research
Austin, Texas 78757

Bellaire Clinical Research
Bellaire, Texas 77401

South Texas Research Institute (STRI) - Brownsville
Brownsville, Texas 78520

Pinnacle Clinical Research
Corpus Christi, Texas 78404

South Texas Research Institute (STRI)
Edinburg, Texas 78539

Dallas Research Institute, LLC
Farmers Branch, Texas 75234

Care United Research
Forney, Texas 75126

Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626

Houston Research Institute - Medical Center
Houston, Texas 770004

Houston Research Institute
Houston, Texas 77079

Houston Research Institute - Pasadena
Pasadena, Texas 77505

Quality Research, Inc.
San Antonio, Texas 78209

Pinnacle Clinical Research - South San Antonio
San Antonio, Texas 78222

Pinnacle Clinical Research
San Antonio, Texas 78229

Sugarland Medical Associates (Sma)
Sugar Land, Texas 77478

Digestive Research of Central Texas
Waco, Texas 76712

Digestive Health Research of North Texas, LLC
Wichita Falls, Texas 76301

GI Select Health Research
Richmond, Virginia 23236

More Details

Status
Recruiting
Sponsor
Eccogene

Study Contact

Eccogene Clinical Trials
86-21-61053022
contact@eccogene.com