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 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EC0010
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 53

Brief 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.

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Keywords

Liver Disease; Nonalcoholic Steatohepatitis; ECC0509; ECC4703

Outcome Measures

Primary Outcomes (1)

• Relative Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo

  Baseline and Week 12

Secondary Outcomes (35)

• Absolute Change from Baseline in Liver Fat Content by MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo

  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

  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

  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

  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

  Baseline and Week 12

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

ECC4703 Low Dose

EXPERIMENTAL

Drug: ECC4703

ECC4703 High Dose

EXPERIMENTAL

Drug: ECC4703

ECC4703 High Dose + ECC0509 High Dose

EXPERIMENTAL

Drug: ECC0509; Drug: ECC4703

ECC0509 Low Dose

EXPERIMENTAL

Drug: ECC0509

ECC0509 High Dose

EXPERIMENTAL

Drug: ECC0509

Interventions

Placebo DRUG

Placebo will be administered as matching oral capsules.

Placebo

ECC0509 DRUG

ECC0509 will be administered as oral capsules.

ECC0509 High Dose; ECC0509 Low Dose; ECC4703 High Dose + ECC0509 High Dose

ECC4703 DRUG

ECC4703 will be administered as oral capsules.

ECC4703 Low Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures.
• 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.
• Evidence of hepatic steatosis confirmed by FibroScan® LSM \> 7 kPa and \< 20 kPa and MRI-PDFF \>8% at screening.
• BMI \>25 kg/m\^2 to \<50 kg/m\^2 (non-Asian); BMI ≥23.0 to \<50.0 kg/m\^2 (Asian).
• ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period.
• Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\^2 (Chronic Kidney Disease Epidemiology Collaboration, \[CKD-EPI\]).
• Stable body weight (no \>5% change) for at least 6 months prior to screening.
• Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).
• In the opinion of the investigator, able to participate safely and complete required MRI/biomarker assessments.

You may not qualify if:

• 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.
• 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).
• ALT and/or AST \>5× Upper Limit of Normal (ULN) or ALP \>2×ULN at screening.
• Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders.
• Type 1 diabetes, HbA1c \>9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.
• 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.
• Significant alcohol use within 1 year prior to screening.
• Recent cardiovascular events, including myocardial infraction (MI), stroke, unstable angina, heart failure (New York heart association \[NYHA III-IV\]), or uncontrolled arrhythmia.
• Current or recent serious psychiatric illness, including psychosis, active suicidal ideation, or suicide attempt within 5 years.
• Pregnancy, breastfeeding, or conditions that increase risk or interfere with study procedures, including MRI contraindications or other investigator-determined safety concerns.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (53)

Arizona Liver Health

Chandler, Arizona, 85224, United States

RECRUITING

Arizona Liver Health - Peoria

Peoria, Arizona, 85381, United States

RECRUITING

Adobe Clinical Research, LLC

Tucson, Arizona, 85712, United States

RECRUITING

Arizona Liver Health - Tucson

Tucson, Arizona, 85712, United States

RECRUITING

Arkansas Gastroenterology, P.A

Little Rock, Arkansas, 71913, United States

RECRUITING

ARcare Center for Clinical Research

Little Rock, Arkansas, 77205, United States

RECRUITING

ARK Clinical Research - Fountain Valley

Fountain Valley, California, 92708, United States

RECRUITING

Ark Clinical Research

Long Beach, California, 90815, United States

RECRUITING

Knowledge Research Center

Orange, California, 92868, United States

RECRUITING

Synergy Healthcare

Bradenton, Florida, 33511, United States

RECRUITING

Synergy Healthcare

Bradenton, Florida, 34209, United States

RECRUITING

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

RECRUITING

Evolution Clinical Trials

Miami, Florida, 33122, United States

RECRUITING

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

RECRUITING

Ocala GI Research

Ocala, Florida, 34471, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

ClinCloud, LLC

Viera, Florida, 32940, United States

RECRUITING

CenExel - iResearch

Decatur, Georgia, 30030, United States

RECRUITING

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

RECRUITING

Digestive Research Alliance of Michiana

South Bend, Indiana, 46635, United States

RECRUITING

Tandem Clinical Research

Covington, Louisiana, 70433, United States

RECRUITING

Tandem Clinical Research

Houma, Louisiana, 70360, United States

RECRUITING

Tandem Clinical Research GI, LLC

Marrero, Louisiana, 70072, United States

RECRUITING

Tandem Clinical Research

Metairie, Louisiana, 70006, United States

RECRUITING

Delta Research Partners

Monroe, Louisiana, 71201, United States

RECRUITING

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

RECRUITING

Delta Research Partners, LLC

West Monroe, Louisiana, 71291, United States

RECRUITING

Mid-Atlantic GI Research

Greenbelt, Maryland, 20770, United States

RECRUITING

Gastrointestinal Associates

Columbia, Missouri, 65201, United States

RECRUITING

Gateway GI Research, LLC

St Louis, Missouri, 63141, United States

RECRUITING

Premier Health Research

Sparta, New Jersey, 07871, United States

RECRUITING

Akron Gastro Research

Akron, Ohio, 44333, United States

RECRUITING

Digestive Specialists

Dayton, Ohio, 45414, United States

RECRUITING

DSI Research

Springboro, Ohio, 45066, United States

RECRUITING

Columbia Gastroenterology Associates, Llc

Columbia, South Carolina, 29204, United States

RECRUITING

Pinnacle Clinical Research

Austin, Texas, 78757, United States

RECRUITING

Bellaire Clinical Research

Bellaire, Texas, 77401, United States

RECRUITING

South Texas Research Institute (STRI) - Brownsville

Brownsville, Texas, 78520, United States

RECRUITING

Pinnacle Clinical Research

Corpus Christi, Texas, 78404, United States

RECRUITING

South Texas Research Institute (STRI)

Edinburg, Texas, 78539, United States

RECRUITING

Dallas Research Institute, LLC

Farmers Branch, Texas, 75234, United States

RECRUITING

Care United Research

Forney, Texas, 75126, United States

RECRUITING

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, 78626, United States

RECRUITING

Houston Research Institute - Medical Center

Houston, Texas, 770004, United States

RECRUITING

Houston Research Institute

Houston, Texas, 77079, United States

RECRUITING

Houston Research Institute - Pasadena

Pasadena, Texas, 77505, United States

RECRUITING

Quality Research, Inc.

San Antonio, Texas, 78209, United States

RECRUITING

Pinnacle Clinical Research - South San Antonio

San Antonio, Texas, 78222, United States

RECRUITING

Pinnacle Clinical Research

San Antonio, Texas, 78229, United States

RECRUITING

Sugarland Medical Associates (Sma)

Sugar Land, Texas, 77478, United States

RECRUITING

Digestive Research of Central Texas

Waco, Texas, 76712, United States

RECRUITING

Digestive Health Research of North Texas, LLC

Wichita Falls, Texas, 76301, United States

RECRUITING

GI Select Health Research

Richmond, Virginia, 23236, United States

RECRUITING

MeSH Terms

Conditions

Liver Diseases; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fatty Liver

Study Officials

• Eccogene Clinical Trials

  Eccogene

  STUDY DIRECTOR

Central Study Contacts

Eccogene Clinical Trials

CONTACT

86-21-61053022; contact@eccogene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 17, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 29, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)