ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)

Key Inclusion Criteria: * Male or female, 18 to 75 years of age * Body mass index (BMI) ≥ 25 kg/m2 * Diagnosis of presumed NASH/MASH with F1-F3 liver fibrosis based on one of the following: * Liver biopsy within 6 months prior to screening showing a NAFLD activity score (NAS) of ≥4 with at least a score of 1 in each of the NAS components; OR * Having ≥2 metabolic syndrome criteria and a screening FibroScan liver stiffness measurement between 7 - 20 kPa * Screening FibroScan with CAP score of \>300 dB/m * Screening MRI-PDFF with ≥10% liver fat content Key Exclusion Criteria: * History or clinical evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) * History or current evidence of cirrhosis * History of liver transplantation or known planned liver transplantation * History or current evidence of a pituitary disorder or hyperthyroidism * Untreated clinical or subclinical hypothyroidism; or on thyroid replacement therapy at screening or within the last 6 months prior to screening. * TSH, free T4, or Total T3 \>1.1 x ULN or \<0.9 x LLN * Clinically concerning abnormal ECG or cardiac history * HbA1c ≥9.5% * Platelet count ≤135,000/mm3 * ALT or AST \>5 x ULN * INR \>1.3 * Albumin \<3.5 g/dL * eGFR \<45 mL/min/1.73 m2

Reproduced word-for-word from the public registry record — the study team can answer questions about it.