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)
NCT ID: NCT07288138
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2025-12-15
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Placebo will be administered as matching oral capsules.
ECC4703 Low Dose
ECC4703
ECC4703 will be administered as oral capsules.
ECC4703 High Dose
ECC4703
ECC4703 will be administered as oral capsules.
ECC4703 High Dose + ECC0509 High Dose
ECC0509
ECC0509 will be administered as oral capsules.
ECC4703
ECC4703 will be administered as oral capsules.
ECC0509 Low Dose
ECC0509
ECC0509 will be administered as oral capsules.
ECC0509 High Dose
ECC0509
ECC0509 will be administered as oral capsules.
Interventions
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Placebo
Placebo will be administered as matching oral capsules.
ECC4703
ECC4703 will be administered as oral capsules.
ECC0509
ECC0509 will be administered as oral capsules.
ECC4703
ECC4703 will be administered as oral capsules.
Eligibility Criteria
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Inclusion Criteria
2. Presumed MASH based on recent liver biopsy (NAFLD activity score \[NAS\] ≥4, fibrosis F1-F3) or non-invasive criteria consistent with liver fibrosis (metabolic syndrome plus FibroScan® liver stiffness 7-14 kPa).
3. Evidence of hepatic steatosis confirmed by FibroScan® CAP \>280 dB/m 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 \>1.5×upper limit of normal (ULN).
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. Evidence of cirrhosis or hepatic decompensation, including prior ascites, varices, encephalopathy, or laboratory/imaging findings consistent with cirrhosis.
3. ALT or AST \>5×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 3 months.
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.
18 Years
ALL
No
Sponsors
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Eccogene
INDUSTRY
Responsible Party
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Principal Investigators
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Eccogene Clinical Trials
Role: STUDY_DIRECTOR
Eccogene
Locations
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Akron Gastro Research
Akron, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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EC0010
Identifier Type: -
Identifier Source: org_study_id
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