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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)

RecruitingPhase 2

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

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Eccogene · Participants: 160 · Started: Dec 15, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07288138

Locations in the U.S.

ArizonaArizona Liver Health, Chandler
Arizona Liver Health - Peoria, Peoria
Adobe Clinical Research, LLC, Tucson
Arizona Liver Health - Tucson, Tucson
ArkansasARcare Center for Clinical Research, Little Rock
Arkansas Gastroenterology, P.A, Little Rock
CaliforniaOm Research, Apple Valley
ARK Clinical Research - Fountain Valley, Fountain Valley
UCSD Medical Center, La Jolla
Om Research, Lancaster
Ark Clinical Research, Long Beach
Knowledge Research Center, Orange
Om Research, Victorville
FloridaSynergy Healthcare, Bradenton
Synergy Healthcare, Bradenton
Health Awareness, Inc., Jupiter
Evolution Clinical Trials, Miami
Floridian Clinical Research, LLC, Miami Lakes
Ocala GI Research, Ocala
Progressive Medical Research, Port Orange
ClinCloud, LLC, Viera
Metabolic Research Institute, West Palm Beach
GeorgiaCenExel - iResearch, Decatur
Gastrointestinal Specialists of Georgia, PC, Marietta
IndianaDigestive Research Alliance of Michiana, South Bend
LouisianaTandem Clinical Research, Covington
Tandem Clinical Research, Houma
Tandem Clinical Research GI, LLC, Marrero
Tandem Clinical Research, Metairie
Delta Research Partners, Monroe
Louisiana Research Center, LLC, Shreveport
Delta Research Partners, LLC, West Monroe
MarylandMid-Atlantic GI Research, Greenbelt
MissouriGastrointestinal Associates, Columbia
Gateway GI Research, LLC, St Louis
NevadaJubilee Clinical Research, Inc, Las Vegas
New JerseyClinical Research Integrity (CRI) Lifetree, LLC, Marlton
Premier Health Research, Sparta
North CarolinaCoastal Research Institute, Fayetteville
OhioAkron Gastro Research, Akron
Digestive Specialists, Dayton
DSI Research, Springboro
Clinical Research Institute of Ohio (CRIOH), LLC, Westlake
South CarolinaColumbia Gastroenterology Associates, Llc, Columbia
TexasPinnacle Clinical Research, Austin
Bellaire Clinical Research, Bellaire
South Texas Research Institute (STRI) - Brownsville, Brownsville
Pinnacle Clinical Research, Corpus Christi
South Texas Research Institute (STRI), Edinburg
Dallas Research Institute, LLC, Farmers Branch
Care United Research, Forney
Evidentis Clinical Research, Fort Worth
Pinnacle Clinical Research - Georgetown, Georgetown
Houston Research Institute, Houston
Houston Research Institute - Medical Center, Houston
Houston Research Institute - Pasadena, Pasadena
Pinnacle Clinical Research, San Antonio
Pinnacle Clinical Research - South San Antonio, San Antonio
Quality Research, Inc., San Antonio
Sugarland Medical Associates (Sma), Sugar Land
Digestive Health Research of North Texas, LLC, Wichita Falls
VirginiaGI Alliance Richmond, Richmond
GI Select Health Research, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.