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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adults ≥18 years of age who can provide written willing to sign a consent form and comply with study procedures. 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. Who Should NOT Join This Trial: Liver-related: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adults ≥18 years of age who can provide written informed consent and comply with study procedures. 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: Liver-related: 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.

Treatments Being Tested

DRUG

Placebo

Placebo will be administered as matching oral capsules.

DRUG

ECC4703

ECC4703 will be administered as oral capsules.

DRUG

ECC0509

ECC0509 will be administered as oral capsules.

DRUG

ECC4703

ECC4703 will be administered as oral capsules.

Locations (20)

Arizona Liver Health
Chandler, Arizona, United States
Arizona Liver Health - Peoria
Peoria, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Arizona Liver Health - Tucson
Tucson, Arizona, United States
Arkansas Gastroenterology, P.A
Little Rock, Arkansas, United States
ARcare Center for Clinical Research
Little Rock, Arkansas, United States
ARK Clinical Research - Fountain Valley
Fountain Valley, California, United States
Ark Clinical Research
Long Beach, California, United States
Synergy Healthcare
Bradenton, Florida, United States
Synergy Healthcare
Bradenton, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Ocala GI Research
Ocala, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
ClinCloud, LLC
Viera, Florida, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, United States
Tandem Clinical Research
Covington, Louisiana, United States
Tandem Clinical Research
Houma, Louisiana, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, United States