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)
Eccogene · NCT07288138
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 160
- US sites recruiting
- 67
- Study start
- December 15, 2025
- Record last updated
- October 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Placebo; ECC4703; ECC0509; ECC4703
Conditions: Metabolic Dysfunction-associated Steatohepatitis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Recruiting US locations
Arizona Liver Health
Chandler, AZ 85224
Arizona Liver Health - Peoria
Peoria, AZ 85381
Adobe Clinical Research, LLC
Tucson, AZ 85712
Arizona Liver Health - Tucson
Tucson, AZ 85712
Arkansas Gastroenterology, P.A
Little Rock, AR 71913
ARcare Center for Clinical Research
Little Rock, AR 77205
Om Research
Apple Valley, CA 92307
ARK Clinical Research - Fountain Valley
Fountain Valley, CA 92708
UCSD Medical Center
La Jolla, CA 92037
Om Research
Lancaster, CA 93534
Ark Clinical Research
Long Beach, CA 90815
Knowledge Research Center
Orange, CA 92868
Om Research
Victorville, CA 92395
Synergy Healthcare
Bradenton, FL 33511
Synergy Healthcare
Bradenton, FL 34209
Health Awareness, Inc.
Jupiter, FL 33458
Evolution Clinical Trials
Miami, FL 33122
Floridian Clinical Research, LLC
Miami Lakes, FL 33016
Ocala GI Research
Ocala, FL 34471
Progressive Medical Research
Port Orange, FL 32127
ClinCloud, LLC
Viera, FL 32940
Metabolic Research Institute
West Palm Beach, FL 33401
CenExel - iResearch
Decatur, GA 30030
Gastrointestinal Specialists of Georgia, PC
Marietta, GA 30060
GI Alliance Glenview
Glenview, IL 60026
GI Alliance Gurnee
Gurnee, IL 60031
Digestive Research Alliance of Michiana
South Bend, IN 46635
Tandem Clinical Research
Covington, LA 70433
Tandem Clinical Research
Houma, LA 70360
Tandem Clinical Research GI, LLC
Marrero, LA 70072
Tandem Clinical Research
Metairie, LA 70006
Delta Research Partners
Monroe, LA 71201
Louisiana Research Center, LLC
Shreveport, LA 71105
Delta Research Partners, LLC
West Monroe, LA 71291
Mid-Atlantic GI Research
Greenbelt, MD 20770
Gastrointestinal Associates
Columbia, MO 65201
Gateway GI Research, LLC
St Louis, MO 63141
Jubilee Clinical Research, Inc
Las Vegas, NV 89106
Clinical Research Integrity (CRI) Lifetree, LLC
Marlton, NJ 08053
Premier Health Research
Sparta, NJ 07871
Coastal Research Institute
Fayetteville, NC 28304
Akron Gastro Research
Akron, OH 44333
Digestive Specialists
Dayton, OH 45414
DSI Research
Springboro, OH 45066
Clinical Research Institute of Ohio (CRIOH), LLC
Westlake, OH 44145
Columbia Gastroenterology Associates, Llc
Columbia, SC 29204
Pinnacle Clinical Research
Austin, TX 78757
Bellaire Clinical Research
Bellaire, TX 77401
South Texas Research Institute (STRI) - Brownsville
Brownsville, TX 78520
Pinnacle Clinical Research
Corpus Christi, TX 78404
South Texas Research Institute (STRI)
Edinburg, TX 78539
Dallas Research Institute, LLC
Farmers Branch, TX 75234
Care United Research
Forney, TX 75126
Evidentis Clinical Research
Fort Worth, TX 76104
GI Alliance Digestive Health Associates of Texas - Garland
Garland, TX 75044
Pinnacle Clinical Research - Georgetown
Georgetown, TX 78626
Houston Research Institute - Medical Center
Houston, TX 770004
Houston Research Institute
Houston, TX 77079
Houston Research Institute - Pasadena
Pasadena, TX 77505
Quality Research, Inc.
San Antonio, TX 78209
+ 7 more on the official record.
Study contacts (from the official record)
- Eccogene Clinical Trials · 86-21-61053022 · contact@eccogene.com
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