Fact CheckerSign in

NCT07288138RecruitingPhase 2

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)

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (estimated)
First submitted
15 Dec 2025
Start date
15 Dec 2025
Primary completion date
15 Sept 2027
Lead sponsor
Eccogene
NCT number
NCT07288138

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 160
  • From 15 Dec 2025 to the primary completion date, 15 Sept 2027
  • 67 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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).
  • Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders.
  • 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.

Lab values

  • ALT and/or AST \>5× Upper Limit of Normal (ULN) or ALP \>2×ULN at screening.
  • Type 1 diabetes, HbA1c \>9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (67)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akron Gastro Research
Coordinator of this site? Confirm its status
AkronUnited StatesRecruiting
Om Research
Coordinator of this site? Confirm its status
Apple ValleyUnited StatesRecruiting
Pinnacle Clinical Research
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Bellaire Clinical Research
Coordinator of this site? Confirm its status
BellaireUnited StatesRecruiting
Synergy Healthcare
Coordinator of this site? Confirm its status
BradentonUnited StatesRecruiting
South Texas Research Institute (STRI) - Brownsville
Coordinator of this site? Confirm its status
BrownsvilleUnited StatesRecruiting
Arizona Liver Health
Coordinator of this site? Confirm its status
ChandlerUnited StatesRecruiting
Gastrointestinal Associates
Coordinator of this site? Confirm its status
ColumbiaUnited StatesRecruiting
Columbia Gastroenterology Associates, Llc
Coordinator of this site? Confirm its status
ColumbiaUnited StatesRecruiting
Pinnacle Clinical Research
Coordinator of this site? Confirm its status
Corpus ChristiUnited StatesRecruiting
Tandem Clinical Research
Coordinator of this site? Confirm its status
CovingtonUnited StatesRecruiting
Digestive Specialists
Coordinator of this site? Confirm its status
DaytonUnited StatesRecruiting
CenExel iResearch
Coordinator of this site? Confirm its status
DecaturUnited StatesRecruiting
South Texas Research Institute (STRI)
Coordinator of this site? Confirm its status
EdinburgUnited StatesRecruiting
Dallas Research Institute, LLC
Coordinator of this site? Confirm its status
Farmers BranchUnited StatesRecruiting
Coastal Research Institute
Coordinator of this site? Confirm its status
FayettevilleUnited StatesRecruiting
Care United Research
Coordinator of this site? Confirm its status
ForneyUnited StatesRecruiting
Evidentis Clinical Research
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
Ark Clinical Research, Fountain Valley
Coordinator of this site? Confirm its status
Fountain ValleyUnited StatesRecruiting
GI Alliance Digestive Health Associates of Texas - Garland
Coordinator of this site? Confirm its status
GarlandUnited StatesRecruiting
Pinnacle Clinical Research - Georgetown
Coordinator of this site? Confirm its status
GeorgetownUnited StatesRecruiting
GI Alliance Glenview
Coordinator of this site? Confirm its status
GlenviewUnited StatesRecruiting
Mid-Atlantic GI Research
Coordinator of this site? Confirm its status
GreenbeltUnited StatesRecruiting
GI Alliance Gurnee
Coordinator of this site? Confirm its status
GurneeUnited StatesRecruiting
Tandem Clinical Research
Coordinator of this site? Confirm its status
HoumaUnited StatesRecruiting
Houston Research Institute - Medical Center
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Houston Research Institute
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Health Awareness, Inc
Coordinator of this site? Confirm its status
JupiterUnited StatesRecruiting
UCSD Medical Center
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Om Research
Coordinator of this site? Confirm its status
LancasterUnited StatesRecruiting
Jubilee Clinical Research, Inc.
Coordinator of this site? Confirm its status
Las VegasUnited StatesRecruiting
Arkansas Gastroenterology, P.A
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
ARcare Center for Clinical Research
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
Ark Clinical Research
Coordinator of this site? Confirm its status
Long BeachUnited StatesRecruiting
Gastrointestinal Specialists of Georgia, PC
Coordinator of this site? Confirm its status
MariettaUnited StatesRecruiting
Clinical Research Integrity (CRI) Lifetree, LLC
Coordinator of this site? Confirm its status
MarltonUnited StatesRecruiting
Tandem Clinical Research GI, LLC
Coordinator of this site? Confirm its status
MarreroUnited StatesRecruiting
Tandem Clinical Research
Coordinator of this site? Confirm its status
MetairieUnited StatesRecruiting
Evolution Clinical Trials
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Floridian Clinical Research, LLC
Coordinator of this site? Confirm its status
Miami LakesUnited StatesRecruiting
Delta Research Partners
Coordinator of this site? Confirm its status
MonroeUnited StatesRecruiting
Ocala GI Research
Coordinator of this site? Confirm its status
OcalaUnited StatesRecruiting
Knowledge Research Center
Coordinator of this site? Confirm its status
OrangeUnited StatesRecruiting
Houston Research Institute - Pasadena
Coordinator of this site? Confirm its status
PasadenaUnited StatesRecruiting
Arizona Liver Health - Peoria
Coordinator of this site? Confirm its status
PeoriaUnited StatesRecruiting
Progressive Medical Research
Coordinator of this site? Confirm its status
Port OrangeUnited StatesRecruiting
GI Alliance Richmond
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
GI Select Health Research
Coordinator of this site? Confirm its status
RichmondUnited StatesRecruiting
Quality Research Inc
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Pinnacle Clinical Research - South San Antonio
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Pinnacle Clinical Research
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Louisiana Research Center, LLC
Coordinator of this site? Confirm its status
ShreveportUnited StatesRecruiting
Digestive Research Alliance of Michiana
Coordinator of this site? Confirm its status
South BendUnited StatesRecruiting
Premier Health Research
Coordinator of this site? Confirm its status
SpartaUnited StatesRecruiting
DSI Research
Coordinator of this site? Confirm its status
SpringboroUnited StatesRecruiting
Gateway GI Research, LLC
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Sugarland Medical Associates (Sma)
Coordinator of this site? Confirm its status
Sugar LandUnited StatesRecruiting
Adobe Clinical Research LLC
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting
Arizona Liver Health - Tucson
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting
Om Research
Coordinator of this site? Confirm its status
VictorvilleUnited StatesRecruiting
ClinCloud, LLC
Coordinator of this site? Confirm its status
VieraUnited StatesRecruiting
Digestive Research of Central Texas
Coordinator of this site? Confirm its status
WacoUnited StatesCompleted
GI Alliance Webster
Coordinator of this site? Confirm its status
WebsterUnited StatesRecruiting
Clinical Research Institute of Ohio (CRIOH), LLC
Coordinator of this site? Confirm its status
WestlakeUnited StatesRecruiting
Delta Research Partners, LLC
Coordinator of this site? Confirm its status
West MonroeUnited StatesRecruiting
Metabolic Research Institute
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesRecruiting
Digestive Health Research of North Texas, LLC
Coordinator of this site? Confirm its status
Wichita FallsUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.