Two experimental medicines, alone and together, for metabolic dysfunction-associated steatohepatitis (MASH)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Liver Health
  Chandler, Arizona, United States Recruiting
• Arizona Liver Health - Peoria
  Peoria, Arizona, United States Recruiting
• Adobe Clinical Research, LLC
  Tucson, Arizona, United States Recruiting
• Arizona Liver Health - Tucson
  Tucson, Arizona, United States Recruiting
• Arkansas Gastroenterology, P.A
  Little Rock, Arkansas, United States Recruiting
• ARcare Center for Clinical Research
  Little Rock, Arkansas, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Eccogene Clinical Trials
• Email: contact@eccogene.com
• Phone: 86-21-61053022

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endohepatology-based reclassification of treatment indication in high-risk MASLD

  This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.

  Recruiting University Hospital Muenster · Münster · NCT07877272

• Pre-hepatectomy rehabilitation with mazdutide for obese MASLD donors

  This trial tests whether adding mazdutide to a structured lifestyle plan helps overweight MASLD donors lose liver fat faster to become eligible for donation.

  Recruiting Phase 4 West China Hospital · Hefei, Anhui and 3 other locations · NCT07718126

• Efimosfermin vs. placebo in adults with compensated cirrhosis from MASH

  This study tests whether Efimosfermin can help adults with compensated cirrhosis due to MASH compared with placebo.

  Recruiting at 35 sites Phase 3 GlaxoSmithKline · Little Rock, Arkansas and 34 other locations · NCT07704892

• Efimosfermin vs placebo in adults with compensated cirrhosis from MASH

  This study tests whether efimosfermin helps adults with compensated cirrhosis caused by MASH compared with placebo.

  Recruiting at 30 sites Phase 3 GlaxoSmithKline · Little Rock, Arkansas and 29 other locations · NCT07701993

• ALN-CIDEB for adults with fibrotic MASH (phase 2)

  This phase 2 study tests ALN-CIDEB versus placebo to see if it can reduce liver fat, injury, and scarring in adults with fibrotic MASH.

  Recruiting at 24 sites Phase 2 Regeneron Pharmaceuticals · Tucson, Arizona and 23 other locations · NCT07631637

• How food affects ECC4703 and how different formulations are absorbed in healthy adults.

  This trial will test how eating and different pill formulations change how ECC4703 is absorbed in healthy adults.

  Recruiting Phase 1 Eccogene · Adelaide, South Australia · NCT07334080

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.