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

Prior treatment

• Untreated clinical or subclinical hypothyroidism; or on thyroid replacement therapy at screening or within the last 6 months prior to screening.

Other illness

• History or clinical evidence of chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)
• History of liver transplantation or known planned liver transplantation
• History or current evidence of a pituitary disorder or hyperthyroidism
• Clinically concerning abnormal ECG or cardiac history

Lab values

• TSH, free T4, or Total T3 \>1.1 x ULN or \<0.9 x LLN
• 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

Other

• History or current evidence of cirrhosis

• 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