Metabolic Dysfunction-associated Steatohepatitis study: ECC4703 vs ECC0509
Official title 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)
ClinicalTrials.gov ID: NCT07288138
What this study is testing
What is ECC4703?
ECC4703 is an investigational medicine, taken by mouth, being studied as a potential treatment for metabolic dysfunction-associated steatohepatitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how different doses of each drug and their combination affect liver fat reduction, measured by MRI after 12 weeks.
- Who it's for
- Adults who have been diagnosed with metabolic dysfunction-associated steatohepatitis.
- What's involved
- Participants will take a low or high dose of the thyroid hormone receptor beta agonist, the SSAO inhibitor, or both, and will have MRI scans to measure liver fat.
- Time commitment
- The trial lasts about 12 weeks and includes regular dosing visits and MRI scans at the start and end.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Evidence of hepatic steatosis confirmed by FibroScan® LSM \> 7 kPa and \ 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.
You likely can't join if
- Chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH, including alcoholic liver disease, autoimmune...
- Presence of cirrhosis on liver histology according to the assessment of the central reader, and/or cross-sectional imaging evidence consistent with...
- 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...
See the full eligibility 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...
- Evidence of hepatic steatosis confirmed by FibroScan® LSM \> 7 kPa and \ 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.
- 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Peoria, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Apple Valley, California, United States
- Fountain Valley, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Orange, California, United States
- Victorville, California, United States
- Bradenton, Florida, United States
- Jupiter, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Ocala, Florida, United States
- Port Orange, Florida, United States
- Viera, Florida, United States
- West Palm Beach, Florida, United States
- Decatur, Georgia, United States
+ 40 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Peoria, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Apple Valley, California, United States; Fountain Valley, California, United States and 54 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.