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)

May 18, 2026 updated by: Eccogene

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Arizona Liver Health
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Arizona Liver Health - Peoria
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Adobe Clinical Research, LLC
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Arizona Liver Health - Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 71913
        • Recruiting
        • Arkansas Gastroenterology, P.A
      • Little Rock, Arkansas, United States, 77205
        • Recruiting
        • ARcare Center for Clinical Research
    • California
      • Apple Valley, California, United States, 92307
        • Recruiting
        • Om Research
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Ark Clinical Research - Fountain Valley
      • Long Beach, California, United States, 90815
        • Recruiting
        • ARK Clinical Research
      • Orange, California, United States, 92868
        • Recruiting
        • Knowledge Research Center
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Synergy Healthcare
      • Bradenton, Florida, United States, 33511
        • Recruiting
        • Synergy Healthcare
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Health Awareness, Inc.
      • Miami, Florida, United States, 33122
        • Recruiting
        • Evolution Clinical Trials
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Floridian Clinical Research, LLC
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Ocala GI Research
      • Port Orange, Florida, United States, 32127
        • Recruiting
        • Progressive Medical Research
      • Viera, Florida, United States, 32940
        • Recruiting
        • ClinCloud, LLC
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Metabolic Research Institute
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel - iResearch
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • South Bend, Indiana, United States, 46635
        • Recruiting
        • Digestive Research Alliance of Michiana
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Tandem Clinical Research
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Tandem Clinical Research
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Tandem Clinical Research GI, LLC
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Tandem Clinical Research
      • Monroe, Louisiana, United States, 71201
        • Recruiting
        • Delta Research Partners
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Louisiana Research Center, LLC
      • West Monroe, Louisiana, United States, 71291
        • Recruiting
        • Delta Research Partners, LLC
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Recruiting
        • Mid-Atlantic GI Research
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Recruiting
        • Gastrointestinal Associates
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Gateway GI Research, LLC
    • New Jersey
      • Sparta, New Jersey, United States, 07871
        • Recruiting
        • Premier Health Research
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Coastal Research Institute
    • Ohio
      • Akron, Ohio, United States, 44333
        • Recruiting
        • Akron Gastro Research
      • Dayton, Ohio, United States, 45414
        • Recruiting
        • Digestive Specialists
      • Springboro, Ohio, United States, 45066
        • Recruiting
        • DSI Research
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • Columbia Gastroenterology Associates, Llc
    • Texas
      • Austin, Texas, United States, 78757
        • Recruiting
        • Pinnacle Clinical Research
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Bellaire Clinical Research
      • Brownsville, Texas, United States, 78520
        • Recruiting
        • South Texas Research Institute (STRI) - Brownsville
      • Corpus Christi, Texas, United States, 78404
        • Recruiting
        • Pinnacle Clinical Research
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • South Texas Research Institute (STRI)
      • Farmers Branch, Texas, United States, 75234
        • Recruiting
        • Dallas Research Institute, LLC
      • Forney, Texas, United States, 75126
        • Recruiting
        • Care United Research
      • Georgetown, Texas, United States, 78626
        • Recruiting
        • Pinnacle Clinical Research - Georgetown
      • Houston, Texas, United States, 77079
        • Recruiting
        • Houston Research Institute
      • Houston, Texas, United States, 770004
        • Recruiting
        • Houston Research Institute - Medical Center
      • Pasadena, Texas, United States, 77505
        • Recruiting
        • Houston Research Institute - Pasadena
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Pinnacle Clinical Research
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • Quality Research, Inc.
      • San Antonio, Texas, United States, 78222
        • Recruiting
        • Pinnacle Clinical Research - South San Antonio
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Sugarland Medical Associates (Sma)
      • Waco, Texas, United States, 76712
        • Recruiting
        • Digestive Research of Central Texas
      • Wichita Falls, Texas, United States, 76301
        • Recruiting
        • Digestive Health Research of North Texas, LLC
    • Virginia
      • Richmond, Virginia, United States, 23236
        • Recruiting
        • GI Select Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: ECC4703
ECC4703 will be administered as oral capsules.
Drug: ECC0509
ECC0509 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo
Time Frame: Baseline and Week 12
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo
Time Frame: Baseline and Week 12
Baseline and Week 12
Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Absolute Change From Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Percentage of Participants With ≥30%, ≥50%, and ≥70% Relative Reduction and Normalization (<5%) in Liver Fat Content by MRI-PDFF, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in Alanine Aminotransferase (ALT), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Percentage of Participants Achieving ≥17-unit Reduction in ALT, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Week 12
Week 12
Percentage of Participants With 30% Reduction in MRI-PDFF, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Week 12
Week 12
Change from Baseline in Aspartate Aminotransferase (AST), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Alkaline Phosphatase (ALP), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Gamma-glutamyl Transferase (GGT), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Fibrosis-4 Index (FIB-4), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in AST to Platelet Ratio Index (APRI), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in FibroScan AST Score (FAST), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Enhanced Liver Fibrosis (ELF) Score, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in MASH Resolution Index, Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in FibroScan Liver Stiffness Measurement (LSM), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in FibroScan Controlled Attenuation Parameter (CAP), Comparing ECC4703 and ECC0509 Monotherapy Versus Placebo, and the Combination of ECC4703 and ECC0509 Versus Each Component
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Total Cholesterol (TC), Triglycerides (TG), High-density Lipoprotein (HDL), Low-density Lipoprotein (LDL) and Apoprotein B (ApoB)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Lipoprotein(a) (Lp[a]) Profiles
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Fasting Insulin
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Profiles
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Body Weight
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline Body Mass Index (BMI)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Plasma Methylamine
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in Cytokeratin-18 (CK-18)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in C-telopeptide of Type III Collagen (CTX-III)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change from Baseline in N-terminal Pro-peptide of Type III Collagen (Pro-C3)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in Ratio of Pro-C3
Time Frame: Week 12
Week 12
Change in Ratio of CTX-III
Time Frame: Week 12
Week 12
Change from Baseline in Chronic Liver Disease Questionnaire (CLDQ)
Time Frame: Baseline and Week 12
Baseline and Week 12
Change from Baseline in Short-form Liver Disease Quality of Life (SF-LDQOL)
Time Frame: Baseline to Week 12
Baseline to Week 12
Plasma Concentration of ECC4703 and ECC0509
Time Frame: Day 1, Weeks 2, 4, 6, 8, and 12
Day 1, Weeks 2, 4, 6, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eccogene

Investigators

  • Study Director: Eccogene Clinical Trials, Eccogene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 29, 2027

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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