Home › Trials › NCT07288138

Two experimental medicines, alone and together, for 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

PHASE2 · Eccogene · NCT07288138

This trial will test whether two experimental drugs (ECC4703 and ECC0509), given alone or together, reduce liver fat in adults with metabolic dysfunction-associated steatohepatitis (MASH).

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorEccogene (industry)
Locations53 sites (Chandler, Arizona and 52 other locations)
Trial IDNCT07288138 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, dose-ranging study comparing low and high doses of ECC4703 and ECC0509, each alone and in combination, versus placebo. Participants are adults aged 18–75 with presumed MASH confirmed by recent biopsy or noninvasive tests and with hepatic steatosis by MRI-PDFF. The primary outcome is change in liver fat measured by MRI-PDFF at Week 12. The trial is conducted at several clinical sites in Arizona.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with presumed MASH (biopsy or FibroScan plus metabolic risk), MRI-PDFF >8%, BMI in the study range, ALT ≥60 U/L, eGFR ≥60 mL/min/1.73m², and stable body weight who can attend study visits and follow contraception rules.

Not a fit: Patients with advanced cirrhosis or other primary liver diseases, significant renal impairment, BMI or lab values outside the inclusion ranges, or who cannot attend required visits are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the drugs could reduce liver fat and potentially slow or improve MASH without invasive procedures.

How similar studies have performed: Thyroid hormone receptor‑beta (THRβ) agonists have shown promise in reducing liver fat in prior trials, while SSAO inhibition is less tested and the combination approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures.
2. 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.
3. Evidence of hepatic steatosis confirmed by FibroScan® LSM \> 7 kPa and \< 20 kPa 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 ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period.
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. 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).
3. ALT and/or AST \>5× Upper Limit of Normal (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 90 days.
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.

Where this trial is running

Chandler, Arizona and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metabolic Dysfunction-associated Steatohepatitis, Liver Disease, Nonalcoholic Steatohepatitis, ECC0509, ECC4703

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.