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)
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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/biomarke